PIANO NAZIONALE DI RIPRESA E RESILIENZA (PNRR) MISSIONE 6 - COMPONENTE 2

PIANO NAZIONALE DI RIPRESA E RESILIENZA (PNRR) MISSIONE 6 - COMPONENTE 2

INVESTIMENTO 2.1 VALORIZZAZIONE E POTENZIAMENTO DELLA RICERCA BIOMEDICA DEL SSN

Convenzione attuativa tra la Direzione generale della ricerca ed innovazione in sanità del Ministero della salute, il Soggetto attuatore/beneficiario ISTITUTO SUPERIORE DI SANITA' e il Principal Investigator della ricerca ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, per la regolamentazione dello svolgimento del progetto Malattie Croniche non Trasmissibili (MCnT) ad alto impatto sui sistemi sanitari e socio- assistenziali con codice progetto PNRR-MAD-2022-12376472, dal titolo BABY@NET: A technology- based National Surveillance Network for the early identification of Autism Spectrum Disorder and other Neurodevelopmental Disorders in at-risk populations;

Premesso che

VISTA la legge 7 agosto 1990, n. 241 “Nuove norme in materia di procedimento amministrativo e di diritto di accesso ai documenti amministrativi” e s.m.i.;

VISTA la legge 14 gennaio 1994 n. 20 “Disposizioni in materia di giurisdizione e controllo della Corte dei Conti” e s.m.i.;

VISTO l’articolo 12 bis, comma 3, del decreto legislativo 30 dicembre 1992, n. 502/1992 e s.m.i.; VISTO il decreto del Presidente del Consiglio dei Ministri 11 febbraio 2014, n. 59, recante il regolamento di organizzazione del Ministero della salute e, in particolare, gli articoli 1, comma 7, e 12, comma 2; VISTO il decreto del Presidente della Repubblica 28 marzo 2013, n. 44, recante il regolamento di riordino degli organi collegiali e degli altri organismi operanti presso il Ministero della salute e, in particolare gli artt. 3 e 4 che prevedono la composizione del Comitato tecnico sanitario;

VISTO il decreto del Ministro della salute 8 agosto 2013, registrato dall’Ufficio centrale di bilancio presso il Ministero della salute in data 13 agosto 2013, visto n. 934 e, in particolare, l’articolo 1, che dispone la ripartizione dei componenti tra le sezioni del Comitato tecnico sanitario;

VISTO il decreto del Ministro della salute 15 dicembre 2021, registrato dall’Ufficio centrale del bilancio presso il Ministero della salute in data 7 gennaio 2022, visto n. 33, recante la ricostituzione del Comitato tecnico sanitario, avente una durata di tre anni dalla data di insediamento;

VISTO il Regolamento (UE) 2021/241 del Parlamento europeo e del Consiglio del 12 febbraio 2021 che istituisce il dispositivo per la ripresa e la resilienza dell’Unione Europea;

VISTO il Piano Nazionale di Ripresa e Resilienza (PNRR) valutato positivamente con Decisione del Consiglio ECOFIN del 13 luglio 2021, notificata all’Italia dal Segretariato generale del Consiglio con nota LT161/21, del 14 luglio 2021, ed in particolare la Missione 6, Componente 2, Investimento 2.1 “Valorizzazione e potenziamento della ricerca biomedica del SSN”, che consiste nel “rafforzare il sistema della ricerca biomedica tramite due linee di intervento: a) il finanziamento di progetti Proof of Concept (PoC), sostenendo lo sviluppo di tecnologie con un basso grado di maturità tecnologica e promuovendo il trasferimento di tecnologie verso l'industria; b) il finanziamento di programmi o progetti di ricerca nel campo delle malattie rare e dei tumori rari e di altre malattie altamente invalidanti”;

VISTO il Regolamento (UE) 2018/1046 del 18 luglio 2018, che stabilisce le regole finanziarie applicabili al bilancio generale dell’Unione, che modifica i Regolamenti (UE) n. 1296/2013, n. 1301/2013, n. 1303/2013, n. 1304/2013, n. 1309/2013, n. 1316/2013, n. 223/2014, n. 283/2014 e la decisione n.

541/2014/UE e abroga il regolamento (UE, Euratom) n. 966/2012;

VISTO il decreto legge del 31 maggio 2021, n. 77, convertito con modificazioni dalla legge 29 luglio 2021, n. 108 «Governance del Piano nazionale di ripresa e resilienza e prime misure di rafforzamento delle strutture amministrative e di accelerazione e snellimento delle procedure»;

VISTO il decreto del Presidente del Consiglio dei ministri 9 luglio 2021 recante l’individuazione delle amministrazioni centrali titolari di interventi previsti nel PNRR, ai sensi dell’articolo 8, comma 1, del

citato decreto legge 31 maggio 2021, n. 77, convertito, con modificazioni, dalla legge 29 luglio 2021, n. 108;

VISTO il decreto del Ministro dell’economia e delle finanze del 6 agosto 2021 relativo all’assegnazione delle risorse in favore di ciascuna Amministrazione titolare degli interventi PNRR e corrispondenti milestone e target;

VISTO il decreto del Ministro della salute, di concerto con il Ministro dell’economia e delle finanze 15 settembre 2021, di istituzione dell’Unità di Missione del Ministero della salute titolare di interventi PNRR, ai sensi dell’articolo 8 del citato decreto legge n. 77 del 2021;

VISTO l’atto di indirizzo del Ministro del 12 ottobre 2021 con il quale sono stati individuati i relativi Soggetti Attuatori nell’ambito degli interventi e sub-interventi di investimento del piano Nazionale di ripresa e resilienza (PNRR) a titolarità del Ministero della salute;

VISTO il decreto legge 6 novembre 2021, n. 152 “Disposizioni urgenti per l'attuazione del Piano nazionale di ripresa e resilienza (PNRR) e per la prevenzione delle infiltrazioni mafiose”;

VISTA la legge 16 gennaio 2003, n. 3 “Disposizioni ordinamentali in materia di pubblica amministrazione” e, in particolare, l’articolo 11, comma 2-bis, ai sensi del quale “Gli atti amministrativi anche di natura regolamentare adottati dalle Amministrazioni di cui all’articolo 1, comma 2, del decreto legislativo 30 marzo 2001, n. 165, che dispongono il finanziamento pubblico o autorizzano l’esecuzione di progetti di investimento pubblico, sono nulli in assenza dei corrispondenti codici di cui al comma 1 che costituiscono elemento essenziale dell'atto stesso”;

VISTA la delibera del CIPE n. 63 del 26 novembre 2020 che introduce la normativa attuativa della riforma del CUP;

VISTO l’articolo 1, comma 1042, della legge 30 dicembre 2020, n. 178 ai sensi del quale con uno o più decreti del Ministro dell’economia e delle finanze sono stabilite le procedure amministrativo-contabili per la gestione delle risorse di cui ai commi da 1037 a 1050, nonché le modalità di rendicontazione della gestione del Fondo di cui al comma 1037;

VISTO l’articolo 1, comma 1043, secondo periodo, della legge 30 dicembre 2020, n. 178, ai sensi del quale al fine di supportare le attività di gestione, di monitoraggio, di rendicontazione e di controllo delle componenti del Next Generation EU, il Ministero dell'economia e delle finanze - Dipartimento della Ragioneria generale dello Stato sviluppa e rende disponibile un apposito sistema informatico;

VISTO l’articolo 17 del Regolamento (UE) 2020/852 che definisce gli obiettivi ambientali, tra cui il principio di non arrecare un danno significativo (DNSH, “Do no significant harm”), e la Comunicazione della Commissione UE 2021/C 58/01“Orientamenti tecnici sull’applicazione del principio «non arrecare un danno significativo» a norma del regolamento sul dispositivo per la ripresa e la resilienza”;

VISTI i principi trasversali previsti dal PNRR, quali, tra l’altro, il principio del contributo all’obiettivo climatico e digitale (c.d. tagging), il principio di parità di genere e l’obbligo di protezione e valorizzazione dei giovani;

VISTI gli obblighi di assicurare il conseguimento di target e milestone e degli obiettivi finanziari stabiliti nel PNRR;

VISTO il Regolamento delegato (UE) 2021/2106 della Commissione del 28 settembre 2021 che integra il regolamento (UE) 2021/241 del Parlamento europeo e del Consiglio, che istituisce il dispositivo per la ripresa e la resilienza, stabilendo gli indicatori comuni e gli elementi dettagliati del quadro di valutazione della ripresa e della resilienza, che prevede, in particolare, che “affinché il quadro di valutazione, compresi gli indicatori comuni, sia aggiornato in modo coerente e uniforme due volte l’anno, tutti gli Stati membri riferiscono alla Commissione due volte l’anno nell’ambito del semestre europeo sui progressi compiuti nella realizzazione dei piani per la ripresa e la resilienza, comprese le modalità operative, e sugli indicatori comuni.”

VISTE le “Linee Guida per lo svolgimento delle attività connesse al monitoraggio del PNRR”, predisposte dal Servizio Centrale per il PNRR, presso il Ministero dell’economia e delle finanze (MEF) - Dipartimento Ragioneria generale dello Stato (RGS), che descriveono le funzionalità del sistema informativo “ReGiS” sviluppato dal Ministero dell’economia e delle finanze – Dipartimento della Ragioneria Generale dello Stato in attuazione dell’articolo 1, comma 1043, della legge 30 dicembre 2020, n. 178;

VISTO il documento “Sistema di Gestione e Controllo (▇▇.▇▇.▇▇.) PNRR - Ministero della salute”, adottato con Decreto del 29 luglio 2022;

VISTE le “Linee Guida per lo svolgimento delle attività di controllo e rendicontazione delle Misure PNRR di competenza delle Amministrazioni centrali e dei Soggetti attuatori”, predisposte dal Servizio Centrale per il PNRR, presso il Ministero dell’economia e delle finanze (MEF) - Dipartimento Ragioneria generale dello Stato (RGS), che contengono indicazioni procedurali per un corretto espletamento delle attività di controllo e rendicontazione delle spese e di Milestone & Target e di ogni altro adempimento previsto dalla normativa comunitaria e nazionale applicabile al PNRR, a norma dell’art. 8, punto 3, del decreto legge 77 del 31 maggio 2021, come modificato dalla legge di conversione 29 luglio 2021, n. 108;

VISTO il decreto del Presidente del Consiglio dei Ministri 15 settembre 2021 “Modalità, regole e strumenti per il conferimento dei dati”;

VISTA la Circolare MEF-RGS del 14 ottobre 2021, n. 21 “Piano Nazionale di Ripresa e Resilienza (PNRR) - Trasmissione delle Istruzioni Tecniche per la selezione dei progetti PNRR”;

VISTO il Decreto interministeriale del 7 dicembre 2021 per l’adozione delle linee guida volte a favorire la pari opportunità di genere e generazionali, nonché l'inclusione lavorativa delle persone con disabilità nei contratti pubblici finanziati con le risorse del PNRR e del PNC;

VISTA la Circolare MEF-RGS del 30 dicembre 2021, n. 32, recante “Guida operativa per il rispetto del principio di non arrecare danno significativo all’ambiente”;

VISTA la Circolare MEF-RGS del 31 dicembre 2021, n. 33 “Piano Nazionale di Ripresa e Resilienza (PNRR) – Nota di chiarimento sulla Circolare del 14 ottobre 2021, n. 21 - Trasmissione delle Istruzioni Tecniche per la selezione dei progetti PNRR – Addizionalità, finanziamento complementare e obbligo di assenza del c.d. doppio finanziamento”

VISTA la Circolare MEF-RGS del 21 giugno 2022, n. 27 “Monitoraggio delle misure PNRR”;

VISTA la Circolare MEF-RGS dell’11 agosto 2022, n. 30 sulle procedure di controllo e rendicontazione delle misure PNRR;

VISTA la Comunicazione della Commissione 2014/C 198/01 “Disciplina degli aiuti di Stato a favore di ricerca, sviluppo e innovazione” e s.m.i.;

VISTO il Regolamento (UE) n. 651/2014 della Commissione, del 17 giugno 2014, che dichiara alcune categorie di aiuti compatibili con il mercato interno in applicazione degli articoli 107 e 108 del trattato; VISTA la comunicazione della Commissione 2016/C 262/01 sulla nozione di aiuto di Stato di cui all'articolo 107, paragrafo 1, del trattato sul funzionamento dell'Unione europea;

VISTA la Comunicazione della Commissione del 19 marzo 2020, C(2020) 1863 “Quadro temporaneo per le misure di aiuto di Stato a sostegno dell'economia nell'attuale emergenza della COVID-19”, da ultimo rettificata attraverso la comunicazione del 18 novembre 2021, C(2021) 8442 “Sesta modifica del quadro temporaneo per le misure di aiuto di Stato a sostegno dell'economia nell'attuale emergenza della COVID- 19 e modifica dell'allegato della comunicazione della Commissione agli Stati membri sull'applicazione degli articoli 107 e 108 del trattato sul funzionamento dell'Unione europea all'assicurazione del credito all'esportazione a breve termine”;

VISTO il decreto del Ministro della salute 1° aprile 2022 che nella relativa tabella ha previsto ai punti

2.1.1 - proof of concept, 2.1.2 – tumori e malattie rare e 2.1.3 – malattie altamente invalidanti, la ripartizione degli interventi di investimento della Missione 6, Componente 2, Investimento 2.1 - del Piano Nazionale di Ripresa e Resilienza relativo all'innovazione, alla ricerca e alla digitalizzazione del Servizio sanitario nazionale e al potenziamento del sistema della ricerca biomedica;

VISTO il I° avviso pubblico per la presentazione e selezione di progetti di ricerca da finanziare nell’ambito del PNRR, pubblicato sul sito web del Ministero della salute il 20 aprile 2022 e sulla gazzetta ufficiale della Repubblica italiana, sulle seguenti tematiche: Proof of concept (PoC), Malattie Rare (MR) con esclusione dei tumori rari, Malattie Croniche non Trasmissibili (MCnT) ad alto impatto sui sistemi sanitari e socio-assistenziali (Fattori di rischio e prevenzione; Eziopatogenesi e meccanismi di malattia); VISTO il decreto direttoriale n. 27 del 2 novembre 2022, registrato con Visto n. 1054 dall’Ufficio centrale di bilancio in data 18 novembre 2022, con il quale è stata approvata la graduatoria dei progetti di ricerca PNRR- Missione 6 - Componente 2 - Investimento 2.1, afferenti alle tematiche progettuali Proof of Concept, Malattie rare, Malattie croniche non trasmissibili, ad alto impatto sui sistemi sanitari e socio- assistenziali (tematiche: Fattori di rischio e prevenzione; Eziopatogenesi e meccanismi di malattia), con il quale si è proceduto ad individuare il Soggetto attuatore/beneficiario e il Principal Investigator; VISTO l’art. 7 del decreto ministeriale 8 aprile 2015, recante il riordino degli uffici di livello dirigenziale non generale del Ministero della salute, ove vengono individuati gli uffici in cui si articola la Direzione

generale della ricerca e dell’innovazione in sanità, indicando le specifiche competenze assegnate agli uffici 3 e 4 della stessa;

VISTO il decreto direttoriale del 1° marzo 2022, registrato dall’Ufficio Centrale di Bilancio in data 4 marzo 2022, al n. 247, con il quale il ▇▇▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ è stato autorizzato, tra l’altro, all’esercizio del potere di spesa e l’ordine di servizio con il quale è stato delegato alla sottoscrizione delle convenzioni per i progetti risultati vincitori nel bando PNRR;

VISTO il decreto direttoriale del 14 dicembre 2022 contenente l'individuazione del ▇▇▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ quale soggetto firmatario per il Ministero di tutte le convenzioni relative ai progetti di ricerca di cui agli avvisi pubblici nell'ambito del PNRR;

VISTO il messaggio trasmesso da questa amministrazione per il tramite della piattaforma WorkFlow della ricerca in data 13 dicembre 2022 con il quale è stato comunicato che la valutazione della proposta progettuale ha avuto esito positivo e che, pertanto, la stessa è stata ammessa a finanziamento;

tanto premesso si stipula e si conviene quanto segue tra

il Ministero della Salute (di seguito “Ministero”), in qualità di Amministrazione titolare, rappresentato dal ▇▇▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ – Direttore dell’Ufficio 3 della Direzione generale della ricerca e dell’innovazione in sanità (di seguito “DGRIC”)

e

Il Soggetto attuatore/beneficiario del progetto, rappresentato dal ▇▇▇▇. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ in qualità di legale rappresentante del ISTITUTO SUPERIORE DI SANITA', codice fiscale 80211730587 (di seguito “Soggetto attuatore-beneficiario”)

e

il Dr ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ (codice fiscale ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇) in qualità di PRINCIPAL INVESTIGATOR del progetto con codice PNRR-MAD-2022-12376472 dal titolo BABY@NET: A technology-based National Surveillance Network for the early identification of Autism Spectrum Disorder and other Neurodevelopmental Disorders in at-risk populations

di seguito congiuntamente definite le “Parti”

Art. 1 Premesse

1. Le premesse sono parte integrante e sostanziale della presente Convenzione.

2. Fa altresì parte integrante e sostanziale della presente Convenzione, quale oggetto della stessa, il progetto di ricerca, i cui contenuti sono definiti ed eventualmente aggiornati nel tempo, mediante condivisione delle parti, senza necessità di espressa nuova sottoscrizione della presente Convenzione.

Art. 2 Soggetto attuatore/beneficiario e Principal Investigator

Il Soggetto attuatore-beneficiario e il Principal Investigator sono i responsabili dell’attuazione del progetto in questione e della regolarità delle relative spese ai sensi del bando e della normativa vigente.

1. È individuato quale Soggetto attuatore/beneficiario ISTITUTO SUPERIORE DI SANITA' codice fiscale 80211730587

2. È individuato quale Principal investigator (di seguito anche “PI”) il ▇▇▇▇. ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, codice fiscale ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇

Art. 3 Oggetto

1. La presente Convenzione disciplina i rapporti tra le Parti per la realizzazione del progetto codice PNRR-MAD-2022-12376472 dal titolo BABY@NET: A technology-based National Surveillance Network for the early identification of Autism Spectrum Disorder and other Neurodevelopmental Disorders in at-risk populations, nell’ambito della realizzazione degli obiettivi previsti dal PNRR, Missione 6 – Componente 2 – Investimento 2.1.

2. La presente Convenzione definisce, tra l’altro, gli obblighi delle Parti, le procedure di rendicontazione e quelle di pagamento.

3. Il soggetto attuatore-beneficiario e il Principal Investigator svolgono il progetto di ricerca secondo quanto riportato nel progetto presentato parte integrante della presente convenzione, e approvato dal Ministero e in ottemperanza a quanto previsto dall’Avviso pubblico.

Art. 4 Termini di attuazione del progetto, durata e importo della Convenzione

1. La presente convenzione ha la durata di 24 mesi prorogabile eventualmente di ulteriori 6 mesi come previsto dal successivo articolo 11.

2. L’attività di ricerca, da svolgersi nell’arco temporale della vigenza della convenzione, deve avere inizio improrogabilmente entro e non oltre il 20 maggio 2023, comunicando la data effettiva di avvio con nota sottoscritta digitalmente dal proprio rappresentante legale e dal Principal investigator della ricerca che deve essere trasmessa almeno 30 giorni prima dell’inizio effettivo, correlata di documentazione di cui al successivo comma 4.

3. Il Soggetto beneficiario entro e non oltre 15 giorni dall’invio della presente convenzione da parte del Ministero per la sottoscrizione provvede alla restituzione della convenzione firmata dal legale rappresentate e controfirmata dal Principal Investigator, tramite il sistema di monitoraggio del WFR, accompagnata dalla comunicazione del codice CUP MASTER del progetto e dei codici fiscali delle singole Unità operative. Le parti riconoscono che il bando di cui alle premesse prevede la decadenza dal finanziamento in caso di inadempienza della presente disposizione.

4. Il Soggetto beneficiario, entro e non oltre30 giorni precedenti la scadenza del termine di cui al comma 2 del presente articolo, pena la decadenza dal finanziamento, è tenuto a trasmettere - con nota sottoscritta digitalmente in maniera congiunta dal proprio rappresentante legale e dal Principal Investigator della ricerca - la seguente documentazione, soggetta a verifica da parte del Ministero al fine di autorizzare l’avvio del progetto:

a) la dichiarazione da parte del legale rappresentante e del Principal Investigator con cui si dichiari che il progetto in questione o parti significative di esso non siano oggetto di altri finanziamenti pubblici a favore dell’Ente attuatore-beneficiario o del Principal Investigator e che, in ogni caso, sarà posta in essere ogni iniziativa volta ad evitare il doppio finanziamento;

b) la dichiarazione da parte del legale rappresentante e del ricercatore responsabile di ciascuna unità operativa partecipante con cui si dichiari che per la propria attività attinente al progetto in questione o per parti significative di esso non siano oggetto di altri finanziamenti pubblici a favore dell’Unità operativa medesima o dei ricercatori di tali unità operative elencati nella proposta progettuale e che, in ogni caso, sarà posta in essere ogni iniziativa volta ad evitare il doppio finanziamento;

c) la dichiarazione da parte degli Enti che svolgono funzioni di unità operativa e dei relativi responsabili di accettazione dei termini della presente convenzione;

d) la dichiarazione con la quale il Soggetto beneficiario attesta che il Principal Investigator svolgerà la propria attività di ricerca, per l’intero periodo relativo all’attuazione del progetto, esclusivamente presso la propria sede o presso la struttura del S.S.N. afferente al medesimo, controfirmata dall’interessato;

e) il parere positivo del Comitato etico competente e/o l’autorizzazione di cui all’articolo 31 del decreto legislativo n. 26 del 4 marzo 2014 riguardante la sperimentazione animale, ove previsti;

f) la comunicazione del codice CUP delle singole Unità operative e per ognuna di esse anche il codice fiscale dei soggetti designati a operare sul sistema ReGiS attraverso specifico

format excel che verrà condiviso da parte della Direzione genale della ricerca e dell’innovazione in sanità che dovrà essere restituito firmato digitalmente;

g) la traduzione in lingua italiana della proposta progettuale senza apportare alcuna modifica alla versione in inglese allegata alla presente convenzione.

5. Per la realizzazione delle attività, l’importo ammesso a finanziamento è pari a 975.000,00€ (Euro novecentosettantacinquemila/00) a valere sulle risorse assegnate per le tematiche progettuali, stanziate in base alla tabella allegata al decreto ministeriale 1° aprile 2022 ai punti 2.1.1 – 2.1.2 e 2.1.3, concernente la ripartizione degli interventi di investimento della Missione 6, Componente 2, Investimento 2.1 del Piano Nazionale di Ripresa e Resilienza relativo all'innovazione, alla ricerca e alla digitalizzazione del Servizio sanitario nazionale e al potenziamento del sistema della ricerca biomedica.

6. La presentazione della richiesta di pagamento della rata intermedia delle spese al Ministero, secondo le modalità previste dall’art. 13, paragrafo 13.1 del bando, dovrà essere effettuata, previo caricamento della documentazione a supporto nel sistema ReGiS, entro 10 giorni dall’invio della comunicazione da parte del Ministero dell’approvazione della relazione scientifica intermedia.

7. La presentazione della richiesta di pagamento finale delle spese al Ministero dovrà essere effettuata successivamente all’invio entro 30 giorni dalla data di conclusione del progetto eventualmente prorogata secondo i termini della presente convenzione della relazione scientifica finale e della relativa rendicontazione economica complessiva del progetto e avverrà solo dopo l’invio della comunicazione da parte del Ministero dell’approvazione della relazione scientifica finale.

8. Il mancato adempimento di quanto previsto dai commi 2 e 3 del presente articolo equivale alla rinuncia a realizzare il progetto e comporta la decadenza dal contributo previsto e la decadenza dal finanziamento.

Art. 5 Obblighi del Soggetto attuatore-beneficiario e del Principal Investigator

1. Con la sottoscrizione della presente Convenzione, il Soggetto attuatore-beneficiario e il Principal Investigator, per quanto di competenza, si obbligano a:

1) assicurare il rispetto di tutte le disposizioni previste dalla normativa comunitaria e nazionale, con particolare riferimento a quanto previsto dal Reg. (UE) 2021/241 e dal D. L. n. 77 del 31/05/2021, convertito con modificazioni dalla L. 29 luglio 2021, n. 108;

2) garantire il rispetto di eventuali previsioni normative, orientamenti o istruzioni tecniche emanate dal Ministero della salute, dal Ministero dell’economia e delle finanze, dalla Commissione Europea ovvero da altri soggetti coinvolti nell’attuazione verifica e controllo delle azioni relative al PNRR, anche successivamente alla sottoscrizione della presente Convenzione;

3) assicurare l’adozione di misure adeguate volte a rispettare il principio di sana gestione finanziaria secondo quanto disciplinato nel Regolamento finanziario (UE, Euratom) 2018/1046 e nell’art. 22 del Regolamento (UE) 2021/241, in particolare in materia di prevenzione e contrasto dei conflitti di interessi, delle frodi, della corruzione, del doppio finanziamento e di recupero e restituzione dei fondi che sono stati indebitamente assegnati;

4) rispettare, a pena di sospensione o revoca del finanziamento in caso di accertata violazione, il principio di “non arrecare danno significativo” (DSNH) agli obiettivi ambientali a norma dell’articolo 17 del Regolamento (UE) 2020/852, i principi trasversali previsti dal PNRR quali, tra l’altro, il principio del contributo all’obiettivo climatico e digitale (c.d. tagging), la parità di genere, producendo dati relativi ai destinatari effettivi dei progetti anche disaggregati per genere (in relazione agli articoli 2, 3, paragrafo 3, del TUE, 8, 10, 19 e 157 del TFUE, e 21 e 23 della Carta dei diritti fondamentali dell’Unione europea), l’obbligo di protezione e valorizzazione dei giovani ed eventuali ulteriori requisiti e condizionalità specifiche dell’investimento oggetto della presente Convenzione;

5) adottare proprie procedure interne, assicurando la conformità ai regolamenti comunitari e a quanto indicato dal Ministero nella descrizione delle funzioni e delle procedure in essere dal Ministero;

6) dare piena attuazione al progetto così come illustrato nel Programma di ricerca, ammesso a finanziamento dal Ministero, garantendo l’avvio tempestivo delle attività progettuali per non

incorrere in ritardi attuativi e concludere il progetto nella forma, nei modi e nei tempi previsti, nel rispetto della tempistica prevista dal relativo cronoprogramma di attuazione e di sottoporre al Ministero le eventuali modifiche al progetto;

7) assicurare il rispetto della normativa vigente sugli aiuti di Stato;

8) assicurare il rispetto dei criteri di ammissibilità delle spese e delle quote percentuali previste dall’Avviso per le varie voci di costo, che saranno calcolate, a consuntivo, sulle spese rendicontate, al netto di eventuali economie riscontrate sul finanziamento assegnato e sulle sole spese eleggibili, dopo verifica da parte del Ministero;

9) garantire, nel caso in cui si faccia ricorso alle procedure di appalto, il rispetto di quanto previsto dal decreto legislativo n. 50/2016 e s.m.i.; rispettare, in caso di ricorso diretto ad esperti esterni all’Amministrazione, la conformità alla pertinente disciplina comunitaria e nazionale, nonché alle eventuali specifiche circolari/disciplinari che potranno essere adottati dal Ministero;

10) individuare eventuali fattori che possano determinare ritardi che incidano in maniera considerevole sulla tempistica attuativa e di spesa definita nel cronoprogramma, relazionando il Ministero sugli stessi;

11) mitigare e gestire i rischi connessi al progetto nonché porre in essere azioni mirate connesse all’andamento gestionale ed alle caratteristiche tecniche;

12) effettuare i controlli ordinari di gestione e di regolarità amministrativo-contabile previsti dalla normativa vigente, e le verifiche sul conflitto di interessi, sul doppio finanziamento e quelle previste dalla normativa antiriciclaggio (“titolare effettivo”);

13) utilizzare il sistema informatico “ReGiS, finalizzato a raccogliere, registrare e archiviare in formato elettronico i dati per ciascuna operazione necessari per la sorveglianza, la valutazione, la gestione finanziaria, la verifica e l’audit, secondo quanto previsto dall’art. 22.2 lettera d) del Regolamento (UE) 2021/241 e tenendo conto delle indicazioni che verranno fornite dagli organi competenti per il tramite del Ministero;

14) caricare sul portale Workflow della Ricerca e nel sistema “ReGiS” la documentazione tecnico scientifica sullo stato di avanzamento del progetto atta a comprovare il corretto svolgimento dello stesso;

15) caricare sul sistema informativo “ReGiS” la documentazione atta a comprovare il corretto svolgimento dei controlli ordinari previsti dalla normativa vigente in merito alle procedure di gara espletate per l’aggiudicazione degli eventuali appalti o subcontratti e eventuali altra documentazione richiesta dalle Amministrazioni centrali deputate alla gestione complessiva del PNRR;

16) garantire la correttezza, l’affidabilità e la congruenza con il tracciato informativo previsto per l’alimentazione del sistema informativo “ReGiS” dei dati di monitoraggio riferiti al CUP Master e ai CUP delle singole Unità operative sull’avanzamento finanziario, fisico e procedurale, e di quelli che comprovano il conseguimento degli obiettivi dell’intervento quantificati in base agli stessi indicatori adottati per le milestones e i target della misura e assicurarne l’inserimento con cadenza almeno bimestrale delle spese (nel termine massimo di 10 giorni successivi all’ultimo giorno del bimestre) nel portale Workflow della Ricerca e sul sistema informativo “ReGiS”, unitamente alla documentazione probatoria pertinente, salvo diversa comunicazione;

17) rispettare l’obbligo di indicazione del CUP su tutti gli atti amministrativo/contabili relativi al progetto e sui documenti collegati alle relative procedure di acquisto e fatturazione;

18) fornire tutte le informazioni richieste relativamente alle procedure e alle verifiche in relazione alle spese rendicontate conformemente alle procedure e agli strumenti adottati dal Ministero;

19) garantire la conservazione della documentazione progettuale in fascicoli cartacei e/o informatici per assicurare la completa tracciabilità delle operazioni - nel rispetto di quanto previsto all’art. 9, punto 4, del D.L. n. 77 del 31 maggio 2021, convertito con modificazioni dalla L. n. 108/2021 - che, nelle diverse fasi di controllo e verifica previste dal sistema di gestione e controllo del PNRR, dovranno essere messi prontamente a disposizione su richiesta dell’Amministrazione centrale titolare di intervento PNRR, del Servizio centrale per il PNRR del MEF, dell’Unità di Audit, della Commissione europea, dell’OLAF, della Corte dei Conti europea (ECA), della Procura europea (EPPO) e delle competenti Autorità giudiziarie nazionali, autorizzando la Commissione, l'OLAF, la Corte dei conti e l'EPPO a esercitare i diritti di cui all'articolo 129, paragrafo 1, del regolamento finanziario (UE; EURATOM) 1046/2018;

20) facilitare le verifiche dell’Ufficio competente per i controlli del Ministero, dell’Unità di Audit, della Commissione europea e di altri organismi autorizzati, che verranno eventualmente effettuate anche attraverso controlli in loco;

21) assicurare che le spese del Progetto di ricerca non siano oggetto, anche parzialmente, di altri finanziamenti, contributi o agevolazioni a valere su fondi pubblici nazionali e/o comunitari (divieto del doppio finanziamento);

22) garantire la disponibilità dei documenti giustificativi relativi alle spese sostenute e ai target realizzati così come previsto ai sensi dell’articolo 9 punto 4 del decreto legge n. 77 del 31/05/2021, convertito in legge 29 luglio 2021, n. 108;

23) predisporre i pagamenti secondo le procedure stabilite dal Ministero, nel rispetto del piano finanziario e cronogramma di spesa approvato, inserendo, allo scadere dei 12 e 24 mesi (prorogabili eventualmente di 6 mesi) nel portale Workflow della Ricerca e sul sistema informativo “ReGiS” i relativi documenti riferiti alle procedure e i giustificativi di spesa e pagamento necessari ai controlli ordinari di legalità e ai controlli amministrativo-contabili previsti dalla legislazione nazionale applicabile, nel rispetto di quanto previsto dall’articolo 22 del Reg. (UE) n. 2021/241 e dell’art. 9 del decreto legge n. 77 del 31/05/2021, convertito in legge 29 luglio 2021, n. 108 la documentazione;

24) assicurare che tutte le spese rendicontate siano state effettuate entro il periodo di svolgimento del progetto e che gli eventuali pagamenti per fatture emesse nel periodo di svolgimento del progetto siano completate entro i 30 giorni successivi alla scadenza progettuale e in tempo utile per il caricamento sul sistema di rendicontazione ReGiS;

25) inoltrare, allo scadere dei 12 e 24 mesi (prorogabili eventualmente di 6 mesi),le richieste di pagamento al Ministero tramite il portale Workflow della Ricerca e/o il sistema informativo “ReGiS” con allegata la rendicontazione dettagliata delle spese effettivamente sostenute e del contributo al perseguimento delle milestones e dei target associati alla misura PNRR di riferimento, unitamente ai documenti giustificativi appropriati secondo le tempistiche e le modalità riportate nei dispositivi attuativi;

26) garantire l’utilizzo di un conto corrente dedicato necessario per l’erogazione dei pagamenti e l’adozione di una contabilità separata o di un’apposita codificazione contabile e informatizzata per tutte le transazioni relative al progetto al fine di assicurare la tracciabilità dell’utilizzo delle risorse del PNRR;

27) assicurare, direttamente o attraverso le Istituzioni da esso dipendenti in cui saranno svolte le attività di ricerca, l’anticipazione delle somme necessarie allo svolgimento della ricerca;

28) partecipare, ove richiesto, alle riunioni convocate dal Ministero.

29) garantire, anche attraverso la trasmissione di relazioni periodiche sullo stato di avanzamento del progetto, che il Ministero riceva tutte le informazioni necessarie, relative alle linee di attività per l’elaborazione delle relazioni annuali di cui all’articolo 31 del Regolamento (UE) n. 2021/241, nonché qualsiasi altra informazione eventualmente richiesta;

30) conseguire il raggiungimento degli obiettivi dell’intervento, quantificati secondo gli stessi indicatori adottati per le milestones e i target della misura PNRR di riferimento, e fornire, su richiesta dal Ministero, le informazioni necessarie per la predisposizione delle dichiarazioni sul conseguimento di target e milestones e delle relazioni e documenti sull’attuazione dei progetti;

31) garantire il rispetto degli obblighi in materia di comunicazione e informazione previsti dall’art. 34 del Regolamento (UE) 2021/241 indicando nella documentazione progettuale che il progetto è finanziato nell’ambito del PNRR, con esplicito riferimento al finanziamento da parte dell’Unione europea e all’iniziativa Next Generation EU (ad es. utilizzando la frase “finanziato dall’Unione europea – Next Generation EU – PNRR M6C2 - Investimento 2.1 Valorizzazione e potenziamento della ricerca biomedica del SSN”), riportando nella documentazione progettuale il logo dell’Unione europea e fornire un’adeguata diffusione e promozione del progetto, anche online, sia web sia social, in linea con quanto previsto dalla Strategia di Comunicazione del PNRR;

32) fornire i documenti e le informazioni necessarie secondo le tempistiche previste e le scadenze stabilite dai Regolamenti comunitari e dal Ministero e per tutta la durata del progetto;

33) garantire una tempestiva diretta informazione agli organi preposti, tenendo informato il Ministero sull’avvio e l’andamento di eventuali procedimenti di carattere giudiziario, civile, penale o amministrativo che dovessero interessare le operazioni oggetto del progetto, comunicare le

irregolarità, le frodi, i casi di corruzione e di conflitti di interessi, nonché i casi di doppio finanziamento, riscontrati a seguito delle verifiche di competenza e adottare le misure necessarie, nel rispetto delle procedure adottate dallo stesso Ministero in linea con quanto indicato dall’art. 22 del Regolamento (UE) 2021/2041;

34) garantire che il Ministero riceva attraverso il sistema “ReGiS” tutte le informazioni necessarie per l’aggiornamento dell’indicatore comune n. 8 “Ricercatori che lavorano in centri di ricerca beneficiari di un sostegno”, riconducibile alla misura oggetto del presente avviso, tenuto conto che, ai sensi dell’art. 3, comma 3, del Regolamento delegato (UE) 2021/2106 della Commissione del 28 settembre 2021 che integra il regolamento (UE) 2021/241 del Parlamento europeo e del Consiglio, che istituisce il dispositivo per la ripresa e la resilienza “la comunicazione di informazioni per l’aggiornamento degli indicatori comuni ha luogo ogni anno entro il 28 febbraio e il 31 agosto. Il periodo di riferimento copre l’intero periodo di attuazione del piano, dal 1° febbraio 2020 in poi, se del caso, fino alle rispettive date limiti del 31 dicembre e del 30 giugno di ogni anno.”

Art. 6 Procedura di monitoraggio e rendicontazione della spesa e dei target

1. Il Ministero con la presente convenzione rappresenta alla controparte che il monitoraggio tecnico- scientifico sarà svolto dalla Direzione della Ricerca ed Innovazione in Sanità, mentre i controlli rispetto alla rendicontazione delle spese saranno svolte dall’Unità di missione per l'attuazione degli interventi del PNRR presso il Ministero della salute.

2. Il Soggetto attuatore-beneficiario, secondo le indicazioni fornite dal Ministero, deve registrare su base almeno bimestrale, entro 10 giorni successivi all’ultimo giorno del periodo considerato, i dati sull’avanzamento finanziario, fisico e procedurale del progetto nel sistema informatico “ReGiS” e implementare tale sistema con la documentazione specifica relativa a ciascuna procedura di affidamento e a ciascun atto giustificativo di spesa e di pagamento, al fine di consentire l’espletamento dei controlli amministrativo-contabili a norma dell’art. 22 del Reg. (UE) 2021/241 da parte dall’Unità di missione per l'attuazione degli interventi del PNRR presso il Ministero della salute.

3. Il Soggetto attuatore-beneficiario, allo scadere dei 12 e 24 mesi (prorogabili eventualmente di 6 mesi) deve trasmettere i dati sull’avanzamento tecnico-scientifico del progetto tramite il portale Workflow della Ricerca e il sistema “ReGiS” corredata di documentazione specifica relativa a ciascuna procedura di affidamento e a ciascun atto giustificativo di spesa e di pagamento, al fine di consentire l’espletamento dei controlli amministrativo-contabili e delle verifiche sullo stato di avanzamento del progetto.

4. Il Soggetto attuatore-beneficiario, pertanto, dovrà inoltrare allo scadere dei 12 e 24 mesi (prorogabili eventualmente di 6 mesi) tramite il portale Workflow della Ricerca e il sistema informatico “ReGiS”, la richiesta rendicontazione delle spese volte a supportare le richieste di pagamento che dovranno essere formalmente trasmesse all’Unità di Missione del Ministero comprensiva dell’elenco di tutte le spese effettivamente sostenute nel periodo di riferimento, gli avanzamenti relativi agli indicatori di intervento/progetto con specifico riferimento alle milestones e ai target del PNRR. Tale richiesta dovrà essere corredata dalla documentazione specificatamente indicata nelle procedure in essere del Ministero.

5. Le spese incluse nelle richieste di pagamento del Soggetto attuatore/beneficiario, se afferenti ad operazioni estratte a campione, sono sottoposte, per il tramite del Sistema Informatico “ReGiS”, alle verifiche, se del caso anche in loco da parte delle strutture deputate al controllo del Ministero.

6. Nello specifico, l’Unità di missione per l'attuazione degli interventi del PNRR del Ministero della Salute e eventuali altre amministrazioni coinvolte a diversi livelli di controllo eseguono le verifiche sulle procedure, sulle spese e sui target in conformità con quanto stabilito dall’art. 22 del Regolamento (UE) 2021/241 al fine di garantire la tutela degli interessi finanziari dell'Unione, la prevenzione, individuazione e rettifica di frodi, di casi di corruzione e di conflitti di interessi, nonché il recupero di somme erroneamente versate o utilizzate in modo non corretto.

7. La Direzione generale della Ricerca ed innovazione in sanità del Ministero della Salute svolge nel merito le funzioni di verifica tecnico-scientifica sullo stato di avanzamento del progetto in questione in coerenza con lo stato di rendicontazione delle spese.

Art. 7 Valutazione intermedia

1. Allo scadere dei 12 mesi dall’inizio dell’attività della ricerca e comunque non oltre trenta (30) giorni da tale termine, il Soggetto attuatore-beneficiario trasmette al Ministero tramite il portale Workflow della ricerca la relazione intermedia sullo stato d’attuazione scientifica della ricerca - sottoscritta digitalmente dal legale rappresentante del Soggetto attuatore/beneficiario e dal Principal Investigator

- contenente la descrizione delle attività progettuali svolte complessivamente e dalle singole unità operative, da cui risulti lo stato avanzamento lavori (SAL) e il regolare svolgimento della ricerca, secondo quanto riportato nel progetto approvato. Tale relazione deve contenere una sintesi, a cura del Principal Investigator, che illustri, nella globalità, lo stato di avanzamento dei lavori, inclusa la descrizione delle attività realizzate da eventuali Enti co-finanziatori e l’apporto fornito da eventuali ▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇ relazione intermedia, previa verifica tecnico-scientifica da parte della Direzione della Ricerca ed innovazione in sanità, sarà caricata dal Soggetto attuatore/beneficiario e dal Principal Investigator all’interno del sistema informativo “ReGiS”.

2. Il Ministero ha facoltà, previa comunicazione preventiva al Soggetto attuatore/beneficiario, di attivare le procedure per la sospensione del finanziamento e il recupero delle somme erogate, comprensive degli eventuali interessi legali maturati, qualora il Soggetto attuatore/beneficiario non adempia a quanto previsto entro i termini di cui al comma 1 del presente articolo.

3. La Direzione generale della Ricerca ed innovazione in sanità del Ministero della Salute, previa comunicazione preventiva al Soggetto attuatore/beneficiario, ha facoltà di comunicare all’Unità di missione per l'attuazione degli interventi del PNRR del medesimo Ministero, che sussistono le condizioni per non erogare le successive quote a rimborso, subordinandole all’ esito positivo del giudizio in ordine alla relazione finale, qualora la relazione intermedia, all’esito dell’istruttoria, non sia considerata idonea a dimostrare che siano stati pienamente raggiunti gli obiettivi medio termine o emerga che essa sia stata condotta non in piena conformità con quanto previsto nel progetto approvato. In tal caso il Ministero potrà procedere con il rimborso a saldo. ▇▇▇▇▇▇▇ non vengano rispettati i termini di cui alla presente convenzione, che non consentano la tempestiva erogazione dei fondi, il Soggetto attuatore/beneficiario esonera il Ministero da qualsiasi responsabilità per eventuali ritardi nell’erogazione delle somme spettanti.

4. Il Ministero, previa comunicazione preventiva al Soggetto attuatore/beneficiario, può sottoporre al Comitato tecnico sanitario sez. c), un dossier, qualora la relazione intermedia, all’esito della istruttoria ministeriale, non consenta di esprimere un compiuto motivato parere. La decisione del suddetto Comitato è vincolante per il Soggetto beneficiario ai fini del prosieguo della convenzione.

Art. 8 Valutazione finale

1. Fatta salva l’eventuale concessione di proroga della durata delle attività progettuali, al termine di ventiquattro mesi - e comunque non oltre trenta (30) giorni dopo la data fissata per il termine della ricerca – ai fini dell’erogazione del saldo, il Soggetto attuatore-beneficiario, con nota firmata digitalmente dal rappresentante legale, trasmette contestualmente al Ministero la seguente documentazione, redatta dal Principal Investigator e recante la firma digitale dello stesso:

- la relazione finale della ricerca, contenente quanto posto in essere anche da eventuali Enti cofinanziatori, che documenti, per ciascuna unità operativa, la coerenza delle attività svolte con il progetto approvato e gli obiettivi raggiunti;

- copia dei lavori pubblicati su riviste impattate a seguito dello svolgimento della ricerca;

- la rendicontazione delle spese sostenute con i fondi ministeriali;

- indicazioni del repository pubblico dove sono resi disponibili i dati grezzi progettuali e quelli utilizzati per le pubblicazioni scientifiche correlate.

- il rispetto dei costi sostenuti rispetto ai vincoli del bando in materia di gender e spese effettuate da parte di istituzioni nell’aree del meridione

2. La rendicontazione economica dovrà essere corredata da una relazione di certificazione e di apposita check list di verifica dei requisiti minimi del bando, rilasciata da un Revisore esterno indipendente, iscritto all’Ordine dei Dottori Commercialisti ed Esperti Contabili e al Registro dei Revisori Legali,

in possesso dei requisiti richiesti dalla Direttiva 2014/56/UE del Parlamento europeo e del Consiglio, del 16 aprile 2014 , che modifica la direttiva 2006/43/CE relativa alle revisioni legali dei conti annuali e dei conti consolidati, e dalla relativa legislazione nazionale di attuazione, che certifichi la regolarità amministrativo-contabile delle spese sostenute per la realizzazione del progetto, la loro conformità alla normativa di riferimento vigente, il rispetto delle condizionalità e di tutti i requisiti previsti dall’Avviso e dalla presente Convenzione il rispetto delle normative nazionali ed europee in materia e la congruenza con le attività svolte ed i risultati raggiunti.

3. Tutta la sopra richiamata documentazione deve essere redatta e trasmessa tramite il portale Workflow della ricerca e il sistema informatico “ReGiS” e secondo le indicazioni previste dal sistema informatico di monitoraggio economico e utilizzando congiuntamente il sistema di comunicazione del Workflow della ricerca, a disposizione dei destinatari istituzionali che può essere integrato con comunicazioni tramite posta elettronica certificata (PEC) da parte del Soggetto attuatore/beneficiario.

4. La documentazione di supporto deve essere a disposizione del Ministero e degli Organi di controllo e verifica del PNRR, presso il Soggetto attuatore/beneficiario, che deve provvedere alla relativa custodia.

5. La Direzione generale della Ricerca ed innovazione in sanità del Ministero della salute provvede ad applicare una decurtazione pari al 10% della rata del saldo, qualora la documentazione di cui al comma 1 del presente articolo sia trasmessa al Ministero in un periodo compreso tra il trentunesimo e il quarantesimo giorno dalla data di conclusione del progetto.

6. Il Ministero provvede ad applicare una decurtazione pari al 20% della rata del saldo, qualora la documentazione di cui al comma 1 del presente articolo sia trasmessa al Ministero in un periodo compreso tra il quarantunesimo e il cinquantesimo giorno dalla data di conclusione del progetto.

7. Il Ministero, previa comunicazione preventiva al Soggetto attuatore/beneficiario, attiva le procedure per la sospensione del finanziamento e la conseguente economia della rata finale, nonché per il recupero di tutte delle somme già erogate, anche quelle già utilizzate per il personale facente parte del gruppo della ricerca, comprensive degli interessi legali maturati, qualora la documentazione di cui al comma 1 del presente articolo non sia trasmessa al Ministero entro il cinquantesimo giorno dalla data di conclusione del progetto.

8. Il Ministero si riserva la facoltà di chiedere informazioni ed eventuale documentazione integrativa al Soggetto attuatore/beneficiario, che deve fornire riscontro entro e non oltre i successivi 15 giorni, qualora:

- la relazione finale non sia considerata idonea a dimostrare il regolare svolgimento della ricerca, in conformità a quanto previsto nel progetto e nel piano finanziario approvati;

- la rendicontazione risulti incompleta o incongruente sia sui dati contabili sia sulle descrizioni.

9. Il Ministero provvederà ad emettere la valutazione finale sulla base di quanto acquisito agli atti. In caso di mancato o esaustivo riscontro da parte del Soggetto attuatore/beneficiario delle richieste di cui al precedente comma, il Ministero comunica al Soggetto attuatore/beneficiario il parere negativo in ordine alla relazione finale e conseguentemente in ordine all’erogazione del saldo ed ha facoltà di chiedere la restituzione delle somme già erogate, comprensive degli interessi legali maturati, in caso di mancato riscontro oppure laddove dall’istruttoria della documentazione integrativa emerga che sono stati disattesi gli obiettivi di cui al progetto

10. Il Ministero, previa comunicazione preventiva al Soggetto attuatore/beneficiario, può sottoporre al Comitato tecnico sanitario sez. c) un dossier, qualora la relazione finale, all’esito della istruttoria ministeriale, non consenta di esprimere un compiuto motivato parere. La decisione del suddetto Comitato è vincolante per il Soggetto beneficiario ai fini del prosieguo della convenzione.

Art. 9 Verifica finanziaria preventiva

Il Soggetto attuatore-beneficiario, al fine dell’erogazione del finanziamento, deve trasmettere al Ministero della salute – Unità di missione per l’attuazione degli investimenti del PNRR, tramite il sistema “ReGiS” la rendicontazione economica corredata da certificato di verifica finanziaria, di cui al comma 2 dell’articolo 8 della presente convenzione, redatto in lingua inglese ed in italiano da parte di soggetti qualificati all’Audit a livello europea, che certifichi la correttezza della procedura di spese,

la completezza della documentazione in base alle disposizioni del bando e alle norme nazionale e a quelle europee

Art. 10 Procedura di pagamento al Soggetto beneficiario

1. Le procedure di erogazione dei fondi su richiesta del Soggetto attuatore/beneficiario a titolo di anticipazione e a titolo di rimborso all’Unità di missione del Ministero della salute seguono le specifiche modalità in conformità con quanto indicato nell’Avviso e di seguito riportate:

- massimo 40% al momento della comunicazione, da parte del Soggetto beneficiario, dell’inizio dell’attività di ricerca, a titolo di anticipazione.

- quota a rimborso per un ulteriore per massimo un complessivo pari all’80% dopo l’invio, al 12° mese dall’inizio delle attività progettuali, da parte del Soggetto attuatore/beneficiario della relazione scientifica intermedia e dopo la sua approvazione, sulla base della presentazione delle richieste di pagamento a titolo di rimborso per le spese effettivamente sostenute dal Soggetto beneficiario, come risultanti dal sistema informatico di cui all’articolo 1, comma 1043, della legge 30 dicembre 2020, n, 178.

- quota a rimborso residuale a saldo, a conclusione della ricerca, dopo l’invio da parte del Soggetto attuatore/beneficiario della relazione scientifica finale e della rendicontazione economica, sulla base della presentazione della richiesta di pagamento finale attestante la conclusione del progetto, in coerenza con le risultanze del sistema di monitoraggio di cui all’articolo 1, comma 1043, della legge 30 dicembre 2020, n. 178.

2. A garanzia della coerenza con l’inizio dell’attività dichiarata, il Soggetto attuatore/beneficiario si impegna ad anticipare le risorse economiche necessarie, nell’eventualità in cui le somme da corrispondersi da parte del Ministero siano in regime di perenzione.

3. ▇▇▇▇▇▇▇ non vengano rispettati i termini di cui alla presente convenzione, che non consentano la tempestiva erogazione dei fondi, il Soggetto attuatore/beneficiario esonera il Ministero da qualsiasi responsabilità per eventuali ritardi nell’erogazione delle somme spettanti.

4. Al termine delle verifiche la Direzione generale della ricerca ed innovazione in sanità del Ministero della Salute comunicherà dall’Unità di missione per l'attuazione degli interventi del PNRR del Ministero Salute le risultanze delle verifiche per consentire l’effettuazione degli eventuali successivi pagamenti.

Art. 11 Variazioni del progetto e del piano dei costi

1. A partire dal 3° mese successivo all’avvio del progetto e fino a 3 mesi prima della scadenza del progetto, il Soggetto attuatore-beneficiario, con nota firmata dal proprio rappresentate legale e dal Principal Investigator, trasmessa tramite il portale Workflow della ricerca e il sistema informatico “ReGiS”, può proporre variazioni al progetto, coerenti con gli obiettivi progettuali, o alla distribuzione di fondi tra le unità operative, purché non comportino un aumento del finanziamento complessivo a carico del Ministero, che dovranno essere accolte con autorizzazione scritta del Ministero. La richiesta di modifica deve dimostrare le necessità scientifiche alla base della richiesta e l’equivalenza della modifica proposta rispetto al raggiungimento degli obiettivi progettuali previsti, modifica che avrà efficacia solo dopo l’approvazione da parte del Ministero con successivo necessario adeguamento del piano dei costi per il CUP Master e per i CUP delle singole Unità operative da parte del Soggetto attuatore-beneficiario.

2. Non è consentito al di fuori del periodo di cui al comma 1 avanzare richieste di modifica. In caso di eventuale necessità di un’ulteriore modifica progettuale è possibile presentare tale richiesta di modifica solo dopo 3 mesi dall’approvazione da parte del Ministero dell’ultima modifica progettuale della stessa tipologia ovverosia scientifica o economica.

3. Il piano dei costi, riportato nella proposta progettuale, è da ritenersi vincolante relativamente al solo totale del finanziamento assegnato e al riparto iniziale tra unità operative, mentre ha valore meramente indicativo per quanto riguarda la ripartizione tra voci di costo e le motivazioni fornite a giustificazione di tali costi.

4. La distribuzione delle somme tra le diverse voci di costo, nell’ambito di ogni singola unità operativa, è consentita sotto la responsabilità del Soggetto attuatore-beneficiario che ha presentato il progetto e che dovrà verificare il rispetto delle percentuali ed i vincoli previste dal bando.

5. Qualsiasi proposta emendativa deve essere adeguatamente motivata dal Principal Investigator per documentare che quanto richiesto risulti indispensabile per assicurare il raggiungimento degli obiettivi a suo tempo prefissati.

6. Solo dopo l’approvazione del Ministero, il soggetto attuatore/beneficiario potrà procedere all’applicazione delle modifiche di cui al comma 1 del presente articolo. In caso di eventuali inadempimenti al presente articolo il Ministero ha facoltà di procedere sia alla risoluzione della convenzione, dandone comunicazione al Soggetto attuatore/beneficiario, sia alla sospensione del finanziamento, nonché al recupero di tutto l’importo erogato.

Art. 12 Proroga

1. Il termine della ricerca può essere prorogato dal Ministero per un periodo massimo di 6 mesi dalla data di scadenza originale, solo a seguito di formale, motivata e documentata istanza firmata digitalmente dal legale rappresentante del Soggetto attuatore-beneficiario e dal Principal Investigator, trasmessa tramite il portale Workflow della ricerca.

2. La richiesta di cui al comma 1 può essere avanzata solo dopo la presentazione della relazione di medio termine ovverosia dopo 12 mesi dall’avvio progetto e fino a 3 mesi precedenti il termine del progetto, con formale e motivata istanza da parte del Soggetto attuatore-beneficiario e del Principal Investigator, che dimostri le necessità scientifiche alla base della richiesta rispetto alle necessità per il raggiungimento degli obiettivi progettuali previsti e avrà efficacia solo dopo l’approvazione da parte del Ministero.

Art. 13 Proprietà e diffusione dei risultati

1. La proprietà degli studi, dei prodotti e delle metodologie sviluppati nell’ambito del progetto è regolamentata dalla normativa vigente in materia, salvo particolari accordi stipulati tra le parti firmatarie del presente atto, ferma restando la possibilità dei soggetti istituzionali del Servizio Sanitario Nazionale di fruirne, previa richiesta alle parti firmatarie.

2. Nel caso in cui il Soggetto attuatore/beneficiario intenda trasferire ad altri soggetti qualsiasi diritto, anche parziale, relativo alla ricerca in questione, ai risultati della stessa o ad eventuali brevetti derivati deve darne preventiva comunicazione al Ministero.

3. Il Soggetto attuatore/beneficiario si impegna a garantire un’adeguata diffusione e promozione del progetto, anche online, sia sul web che sui social media.

4. Qualsiasi documento prodotto, ivi comprese le pubblicazioni scientifiche inerenti al progetto di ricerca oggetto della presente convenzione – per i quali deve essere assicurato l’accesso non oneroso al Ministero - deve contenere l’indicazione che il progetto è finanziato nell’ambito del PNRR, con un’esplicita dichiarazione che reciti "finanziato dall’Unione europea – Next Generation EU – PNRR M6C2 - Investimento 2.1 Valorizzazione e potenziamento della ricerca biomedica del SSN", l’emblema dell’Unione Europea ed il codice del progetto.

5. I prodotti di cui al precedente comma 4 devono essere resi pubblici attraverso sistemi che consentano l’immediata fruizione da parte del pubblico (ad esempio open-access) e non potranno essere oggetto di pubblicazione scientifica per la quale sia necessario il pagamento di una sottoscrizione ovvero il pagamento per la consultazione relativa L’eventuale violazione del presente comma, anche per una sola pubblicazione, sarà oggetto di una penale pari al 25% del finanziamento complessivo

6. Il Ministero non riconosce l’eleggibilità dei costi delle pubblicazioni sui propri fondi qualora in dette pubblicazioni non si faccia espressa menzione del finanziamento ottenuto nell’ambito del PNRR e del codice progetto.

7. Le parti convengono che il Ministero possa dare direttamente diffusione, anche attraverso il proprio sito web, dell’estratto della proposta progettuale e dei risultati della ricerca sia in forma completa che sintetica e delle pubblicazioni scientifiche da essa derivate.

Art. 14 Casi di riduzione, sospensione o revoca del contributo

1. Il Ministero procede a dichiarare la sospensione o revoca totale o parziale del finanziamento concesso, con conseguente eventuale restituzione delle somme già erogate, comprensive degli interessi legali maturati, nei seguenti casi:

a. modifiche ingiustificate alla composizione del gruppo di ricerca;

b. mancato rispetto dei vincoli previsti dall’Avviso;

c. mancato rispetto degli obblighi di cui all’art. 5 della presente Convenzione;

d. mancato raggiungimento, nei tempi assegnati, delle milestones e dei target previsti per lo svolgimento del progetto;

e. mancata o ritardata presentazione della relazione intermedia sullo stato d’attuazione della ricerca;

f. mancata o ritardata presentazione - oltre il cinquantesimo giorno dalla data di conclusione del progetto - della relazione finale della ricerca e della rendicontazione delle spese sostenute con i fondi ministeriali;

g. modifiche del progetto o variazioni nella distribuzione dei fondi tra le unità operative non autorizzate;

2. Il Ministero applica riduzioni finanziarie in misura variabile e/o consistenti nel mancato riconoscimento delle spese nei seguenti casi:

a. mancato rispetto dei criteri di ammissibilità di cui all’art. 10 dell’Avviso; spese eccedenti i massimali previsti per alcune categorie di spese dall’art. 10 dell’Avviso; costi delle pubblicazioni in cui non si faccia espressa menzione del finanziamento ottenuto nell’ambito del PNRR e del codice progetto;

b. riduzione finanziaria nella misura del 5% della rata del saldo nel caso in cui il Soggetto attuatore/beneficiario al termine delle attività progettuali inoltri copia dei lavori pubblicati su riviste impattate a seguito dello svolgimento della ricerca dalla quale risulti che solo alcune pubblicazioni prodotte recano la menzione del finanziamento ottenuto nell’ambito del PNRR e del codice progetto;

c. riduzione finanziaria nella misura del 10% della rata del saldo qualora la relazione finale della ricerca e la rendicontazione delle spese sostenute siano trasmesse al Ministero in un periodo compreso tra il trentunesimo e il quarantesimo giorno dalla data di conclusione del progetto;

d. riduzione finanziaria nella misura del 20% della rata del saldo qualora la relazione finale della ricerca e la rendicontazione delle spese sostenute siano trasmesse al Ministero in un periodo compreso tra il quarantunesimo e il cinquantesimo giorno dalla data di conclusione del progetto;

e. riduzione finanziaria nella misura del 5% dell’intero finanziamento nel caso in cui il Soggetto attuatore/beneficiario al termine delle attività progettuali inoltri copia dei lavori pubblicati su riviste impattate a seguito dello svolgimento della ricerca privi della menzione del finanziamento ottenuto nell’ambito del PNRR e del codice progetto;

f. riduzione finanziaria nella misura del 10% dell’intero finanziamento nel caso in cui il Soggetto attuatore/beneficiario al termine delle attività progettuali non inoltri la copia dei lavori pubblicati su riviste impattate a seguito dello svolgimento della ricerca e/o le indicazioni del repository pubblico dove sono resi disponibili i dati grezzi progettuali e quelli utilizzati per le pubblicazioni scientifiche correlate.

Art. 15 Risoluzione di controversie

1. Per qualsiasi controversia, il Soggetto attuatore-beneficiario può rivolgersi agli Uffici della Direzione generale della ricerca e dell’innovazione in sanità del Ministero della salute, che sottoporranno le eventuali problematiche al parere di competenza del Comitato tecnico sanitario (CTS) operante presso il Ministero. Le parti, con la sottoscrizione della presente convenzione, accettano fin d’ora il parere

che sarà espresso dal Comitato tecnico sanitario (CTS) in caso di controversie sulla conduzione scientifica del progetto e le eventuali ricadute economiche.

2. Con la firma della presente convenzione il Principal Investigator accetta quanto previsto dal precedente comma 1.

3. Qualora a seguito della valutazione del CTS, di cui al comma 1 sussistano ulteriori eventuali controversie, diverse da quelle del comma 1, che dovessero sorgere in ordine al presente avviso il Foro competente è il Foro di Roma.

Art. 16 Risoluzione per inadempimento

1. Il Ministero potrà avvalersi della facoltà di risolvere la presente Convenzione qualora il Soggetto attuatore/beneficiario non rispetti gli obblighi imposti a suo carico e, comunque, pregiudichi l’assolvimento da parte dello stesso Ministero degli obblighi imposti dalla normativa comunitaria.

Art. 17 Diritto di recesso

1. Il Ministero potrà recedere in qualunque momento dagli impegni assunti con la presente Convenzione nei confronti del ▇▇▇▇▇▇▇▇ attuatore/beneficiario qualora, a proprio giudizio, nel corso di svolgimento delle attività, intervengano fatti o provvedimenti che modifichino la situazione esistente all’atto della stipula della presente Convenzione o ne rendano impossibile o inopportuna la conduzione a termine.

Art. 18 Comunicazioni e scambio di informazioni

1. Ai fini della digitalizzazione dell’intero ciclo di vita del progetto, tutte le comunicazioni con il Ministero della salute devono avvenire attraverso il sistema di monitoraggio delle ricerche denominato Workflow della ricerca, a disposizione del Soggetto attuatore-beneficiario e laddove necessario attraverso il sistema messo a disposizione dal Ministero dell’Economie e Finanze denominato “ReGiS”.

2. Il Soggetto attuatore/beneficiario attraverso il proprio rappresentate legale, nonché il Principal Investigator devono firmare digitalmente tutti gli atti inerenti alla ricerca.

Art. 19 Tracciabilità dei flussi finanziari

1. Le parti si impegnano all’osservanza, per quanto di rispettiva competenza, delle disposizioni inerenti alla tracciabilità dei flussi finanziari di cui all’art. 3 della Legge 13 agosto 2010, n. 136 e s.m.i..

Art. 20 Protezione dei dati personali

1. Nel corso dell’esecuzione delle attività oggetto della presente Convenzione, ciascuna delle Parti potrà trovarsi nella condizione di dover trattare dati personali riferibili a dipendenti e/o collaboratori dell’altra Parte, motivo per cui le stesse si impegnano sin d’ora a procedere al trattamento di tali dati personali in conformità alle disposizioni di cui al Regolamento (UE) 2016/679 del Parlamento europeo e del Consiglio, del 27 aprile 2016, relativo alla protezione delle persone fisiche con riguardo al trattamento dei dati personali, nonché alla libera circolazione di tali dati e che abroga la direttiva 95/46/CE (Regolamento generale sulla protezione dei dati - GDPR) e successive norme nazionali di adeguamento.

2. Le Parti si impegnano a condurre le suddette attività di trattamento sulla base dei principi di correttezza, liceità, trasparenza e tutela della riservatezza dei soggetti interessati e per il solo ed esclusivo fine di perseguire le finalità di cui alla presente Convenzione, nonché degli eventuali obblighi di legge allo stesso connessi. Tali dati saranno trattati dalle Parti con sistemi cartacei e/o automatizzati

- ad opera di propri dipendenti e/o collaboratori che, in ragione della propria funzione e/o attività, hanno la necessità di trattarli, per le sole finalità suindicate e limitatamente al periodo di tempo necessario al loro conseguimento.

Art. 21 Efficacia

1. La presente convenzione, vincolante all'atto della sottoscrizione per il Soggetto attuatore-beneficiario e il Principal Investigator, diventerà efficace per il Ministero a seguito della registrazione da parte degli organi di controllo.

Art. 22 Disposizioni Finali

1. Per quanto non previsto dalla presente Convenzione si rinvia alle norme comunitarie e nazionali di riferimento.

Letto, confermato e sottoscritto con firma digitale, ai sensi del decreto legislativo 7 marzo 2005, n. 82 e s.m.i..

Roma, (data della sottoscrizione come quella dell’ultima firma digitale apposta) per il Ministero della salute

▇▇▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ Direttore dell’Ufficio 3

Direzione generale della ricerca e dell’innovazione in sanità

per il Soggetto attuatore/beneficiario ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇, codice fiscale ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇ (Legale rappresentante)

Per presa visione ed accettazione:

Il Principal Investigator - ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, codice fiscale ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇

1 - General information

Project code: PNRR-MAD-2022-12376472

PI / Coordinator: ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇

Project topic: C1) Malattie croniche non trasmissibili, ad alto impatto sui sistemi sanitari e socio-assistenziali: fattori di rischio e prevenzione

Applicant Institution: Istituto Superiore di Sanita'

Call section: Proposal title:

Malattie Croniche non Trasmissibili (MCnT) ad alto impatto sui sistemi sanitari e socio-assistenziali

BABY@NET: A technology-based National Surveillance Network for the early identification of Autism Spectrum Disorder and other Neurodevelopmental Disorders in at-risk populations

Duration in months: 24

MDC primary: Pediatria MDC secondary: Psichiatria Project Classification IRG:

Brain Disorders and Clinical Neuroscience

Project Classification SS:

Developmental Brain Disorders - DBD

X

Project Keyword 1:

Developmental disorders: Mental retardation, learning disabilities, specific language impairment, dyslexia, autism, cerebral palsy, sudden infant death syndrome - SIDS, and other relevant disorders.

Project Request: Animals:

Project total financing request to the MOH: € 975.000

Humans:

Clinical trial:

Free keywords: At-risk infants, prematurity, small for gestational age, tele-health, surveillance, biostatistics, risk factors, prevention, EEG, genetics, epigenetics, metabolomic, secretome

Declarations

In case of a Synergy grant application 'Principal Investigator'(PI) means 'corresponding Principal Investigator on behalf of all Principal Investigators', and 'Host Institution' means 'corresponding Host Institution'.

1) The Principal Investigator declares to have the written consent of all participants on their participation and on the content of this proposal, as well as of any researcher mentioned in the proposal as participating in the project (either as other PI, team member or collaborator).	X
2) The Principal Investigator declares that the information contained in this proposal is correct and complete.	X
3) The Principal Investigator declares that all parts of this proposal comply with ethical principles (including the highest standards of research integrity — as set out, for instance, in the European Code of Conduct for Research Integrity — and including, in particular, avoiding fabrication, falsification, plagiarism or other research misconduct).	X
4) The Principal Investigator is only responsible for the correctness of the information relating to his/her own organisation. Each applicant remains responsible for the correctness of the information related to him and declared above.	X

Personal data protection

The assessment of your grant application will involve the collection and processing of personal data (such as your name, address and CV), which will be performed pursuant to Regulation (EC) No 45/2001 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data. Unless indicated otherwise, your replies to the questions in this form and any personal data requested are required to assess your grant application in accordance with the specifications of the call for proposals and will be processed solely for that purpose. Details concerning the purposes and means of the processing of your personal data as well as information on how to exercise your rights are available in the privacy statement. Applicants may lodge a complaint about the processing of their personal data with the European Data Protection Supervisor at any time.

Abstract

Autism spectrum disorder (ASD) is a neurodevelopmental disorder (NDD) that affects about 78 million people worldwide. Its prevalence and degree of impact on individuals and families place it among disorders of global importance. ASD resulted in

4.31 million (95% UI 2.82-6.23) global Disability-Adjusted Life Years (DALYs) in 2019, equivalent to 0.2% (0.1-0.2) of ▇▇▇▇▇ and contributed to 3.4% (2.7-4.3) of DALYs for the aggregate of mental disorders. Evidence shows that early and tailored intervention limits the impact of symptomatology and improves the quality of life of people with ASD and other NDDs and their families.

Early identification of clinical signs (red flags) is the first step to facilitating prompt referral for an assessment and diagnosis. In many cases, features of ASD/NDDs manifest early in development (first 6-12 months), although the specificity of these signs is still unclear.

Three infants' populations are at higher risk for developing ASD/NDDs compared to the general population: siblings of children diagnosed with ASD (18.7%), preterms, and Small for Gestational Age (SGA). In preterm infants, the prevalence of ASD has been estimated as 7% (95% IC, 4-9) and ADHD is diagnosed twice as often (OR: 1.6; 95% CI: 1.3-1.8). Moreover, the risk for developing ASD in SGA has been estimated as 1.17 (95% CI, 1.09-1.24).

Setting up a system to monitor infant neurodevelopmental trajectories through a specific experimental and clinical protocol will enable strategic preventive actions. Early detection of ASD/NDDs requires the mainstreaming of child development monitoring into Child Psychiatry Units (CPUs) and Neonatal Intensive Care Units (NICUs) follow-up programs of at-risk infants. Since 2010, the UO1 coordinates the Italian Network for early detection of Autism Spectrum Disorders (NIDA Network), actually involving 45 NICUs and 148 CPUs implicated in the diagnosis and treatment of infants at risk for ASD/NDDs in all Italian Regions. Within the NIDA Network, UO1 implemented a clinical protocol for monitoring at-risk infants for ASD/NDDs in the NICUs follow-up and CPUs. However, the implementation of the protocol in the clinical routine practice requires human resources with specific competences in child psychiatry test scoring and motor/vocal/social behavioral analysis.

The BABY@NET project will add to our 6-to-36 months well-established clinical NIDA protocol, the experimental data collection and analysis of behavioral and neurophysiological/biological features (vocal, motor, social, EEG, genetic/epigenetic, metabolomic, and secretome), in the first 12 months of age, found altered in ASD/NDDs children. The existing IT platform will be improved for collecting research data, audios/videos, tests and providing the telehealth support to those NICUs and CPUs that suffer from shortage of human resources and competences in testing and video scoring of high- risk infants.

Through statistical analysis of clinical, behavioral, and neurophysiological/biological endpoints, it is possible to identify early risk signals that can significantly anticipate ASD/NDDs diagnoses in at-risk and general populations. The clinical/experimental protocol combined with the digital infrastructure (e-health) will be implemented in NICUs and CPUs throughout the National Health Service (NHS) ensuring the population of at-risk newborns a specialized assessment, the neurodevelopmental surveillance and activation of personalized prevention interventions.

Yes

In order to best review your application, do you agree that the above non-confidential proposal title and abstract can be used, without disclosing your identity, when contacting potential reviewers?

2 - Participants & contacts

Operative Units
Institution that perform as UO	CF Institution	Department / Division / Laboratory	Role in the project	Southern Italy	SSN
1 - Istituto Superiore di Sanita'	80211730587	Research Coordination and Support Service	Coordination of the UOs: clinical/experimental surveillance protocol, biostatistical analysis and dissemination of results		X
2 - Fondazione IRCCS Policlinico Ca' Granda	04724150968	Neonatology and neonatal Intensive Care Unit	Coordination of the NICUs and related follow-up services, preterms biological sampling and analysis		X
3 - IRCCS Medea	00307430132	Child Psychopathology Unit	Infants recruitment, assessment and experimental testing		X
4 - Azienda Ospedaliera Universitaria ▇▇▇▇▇▇▇▇ ▇▇, Regione Campania	00876220633	Department of Maternal-Infantile - Child and Adolescent Neuropsychiatry Unit	Infants recruitment, assessment and experimental testing, preterms biological sampling and analysis	X	X

Principal Research Collaborators
Key Personnel Name	Operative Unit	Role in the project
1 - ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇	Istituto Superiore di Sanita'	Co-PI: biostatistical analysis of data collected by the BABY@NET surveillance protocol
2 - Mosca ▇▇▇▇▇	▇▇▇▇▇▇▇▇▇▇ IRCCS Policlinico Ca' Granda	Coordinator of UO2: implementation of the surveillance program in the NICUs and related follow-up services
3 - ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇	Fondazione IRCCS Policlinico Ca' Granda	Research collaborator: enrollment of preterms/SGA and responsible for the epigenetic analysis
4 - ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	IRCCS Medea	Coordinator of UO3: supervising and organizing siblings recruitment and testing
5 - ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	▇▇▇▇▇▇▇ Ospedaliera Universitaria ▇▇▇▇▇▇▇▇ ▇▇, Regione Campania	Coordinator of UO4: recruitment and clinical/experimental evaluation of infants/children enrolled in the project, biological sampling and metabolomic analysis
6 Under 40 - ▇▇▇▇ ▇▇▇▇▇▇▇▇▇	IRCCS Medea	Research collaborator: recruitment, clinical/experimental evaluations of at-risk populations
7 Under 40 - ▇▇▇▇▇▇ ▇▇▇▇▇▇	▇▇▇▇▇▇▇ Ospedaliera Universitaria ▇▇▇▇▇▇▇▇ ▇▇, Regione Campania	Research collaborator: recruitment, clinical/experimental evaluations of at-risk populations

Key Personnel Name	Co-PI	Resp. CE	Resp. Animal	Birth Date	Gender
1 - ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇	X			17/12/1962	M
2 - Mosca ▇▇▇▇▇				05/08/1955	M
3 - ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇				18/03/1969	F
4 - ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇				21/04/1957	M
5 - ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇				10/06/1968	F
6 Under 40 - ▇▇▇▇ ▇▇▇▇▇▇▇▇▇				▇▇/▇▇/▇▇▇▇	▇
7 Under 40 - ▇▇▇▇▇▇ ▇▇▇▇▇▇				13/12/1982	M

Additional research collaborators under 40 to hire
Key Personnel Name	Operative Unit	Birth Date	Gender	Role in the project	Degree	Actual Pos. and Inst.
0 - ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	Istituto Superiore di Sanita'	04/09/1982	M	Processing and immunometric analysis of biological samples	Biologist (Master's Degree in Science - Human Evolution and Biology)	Post-doctoral Fellowships, Fondazione ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
1 - ▇▇▇▇▇▇▇ ▇▇▇▇▇▇	▇▇▇▇▇▇▇ Ospedaliera Universitaria ▇▇▇▇▇▇▇▇ ▇▇, Regione Campania	26/06/1982	F	Infants recruitment and assessment, data-entry and test scoring	Psychology (Master's Degree)	Consultant (Psychologist) Villa delle Ginestre, Neurorehabilitatio n Center
2 - ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇	▇▇▇▇▇▇▇ Ospedaliera Universitaria ▇▇▇▇▇▇▇▇ ▇▇, Regione Campania	23/01/1991	M	Infants recruitment and assessment, EEG and data-entry	Child psychiatrist (Residency)	Clinical Consultant (Child Psychiatrist) Casa di cura Santa ▇▇▇▇▇ del pozzo, Neurorehabilitatio n Center

2.1 Administrative data of participating

Operative Unit Number 1:

Address: Istituto Superiore di Sanità, Servizio di coordinamento e supporto alla ricerca, ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇, ▇▇▇▇, ▇▇▇▇▇

PEC: ▇▇▇▇▇▇▇▇▇▇.▇▇▇▇▇▇▇▇@▇▇▇.▇▇▇.▇▇

Operative Unit Number 2:

Address: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, ▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇

PEC: ▇▇▇▇▇▇▇▇▇▇@▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇.▇▇

Operative Unit Number 3:

Address: IRCCS MEDEA - Associazione La Nostra Famiglia, ▇▇▇ ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇, ▇ - ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ (▇▇▇▇), ▇▇▇▇▇

PEC: ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇▇▇▇▇▇▇▇@▇▇▇.▇▇

Operative Unit Number 4:

Address: Azienda Ospedaliera Universitaria ▇▇▇▇▇▇▇▇ ▇▇, UOSD Child Psychiatry, ▇▇▇ ▇▇▇▇▇▇▇ ▇, ▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇

PEC: ▇▇▇.▇▇▇▇▇▇▇▇▇▇@▇▇▇.▇▇

Operative Unit Number 5 (self financing):

Address: None

PEC: None

2.2 Principal Investigator (PI) Profile

Last Name: SCATTONI

First Name: ▇▇▇▇▇ ▇▇▇▇▇

Last name at birth:

Gender: F

Title: Principal investigator Nationality: ITALIANA Date of birth: 22/08/1973

Official H index (Scopus or Web of Science): 30.0

Country of residence: ITALY Country of Birth: ITALY Place of Birth: Tivoli

Scopus Author Id:▇▇▇▇▇▇▇▇▇▇ ORCID ID:0000-0002-6659-0280 RESEARCH ID:K-4116-2016

Contact address

Current organisation name: Istituto Superiore di Sanita'

Current Department / Faculty / Institute / Laboratory name: Research Coordination and Support Service

Street: ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇

Postcode / Cedex: 00161 Town: Roma

Phone:▇▇▇▇▇▇▇▇▇▇▇▇▇ Phone 2: ▇▇▇-▇▇▇▇▇▇▇

Education / training
Educational institution and location	Degree	Field of study	From year	To year
University La Sapienza, Rome, Italy	Single-cycle master's degree / Laurea magistrale a ciclo unico	Biological Science, Psychobiology Program	1993	2002
University La Tuscia, Viterbo, Italy	Specialization / Specializzazione	Professional qualification in Biology	2003	2003
University La Sapienza, Rome, Italy	PhD	Pharmacology and Toxicology	2002	2005
University Cattolica del Sacro Cuore, Graduate School of Health Economics and Management, Rome, Italy	Specialization / Specializzazione	Organization and Management of Health Services	2020	2021

Personal Statement:

Our proposal aims to implement a technology-based national surveillance network for the identification of early risk factors for ASD/NDDs in at-risk populations and prevention strategies in the National Health Service. Dr. Scattoni will coordinate the project and be responsible for the recruitment and follow-up of at-risk infants in all Child Psychiatry and Neonatal Intensive Care Units involved in the study and lead the telehealth team and data analysis. Since 2010, she has been Principal Investigator of the Italian Network for Early Detection of ASD and has gained extensive experience in coordinating clinical networks among pediatricians, child neuropsychiatrists, and neonatologists dedicated to the identification of early markers of NDDs in high-risk populations.

Positions and honors

Positions
Institution	Division / Research group	Location	Position	From year	To year
Istituto Superiore di Sanità	Behavioural Neuroscience Section	Rome, Italy	Scientific Guest	2000	2002
Istituto Superiore di Sanità	Behavioural Neuroscience Section	Rome, Italy	Researcher Associate	2002	2006
University of Cambridge	Brain Repair Centre and Neurology Unit, Department of Clinical Neurosciences	Cambridge, UK	Visiting Foreign Fellow	2005	2005
National Institute of Mental Health/NIH	Behavioral Neuroscience Section	Bethesda, USA	Postdoctoral fellowship	2006	2009
Istituto Superiore di Sanità	Neurotoxicology and Neuroendocrinology Section, Dept. Cell Biology and Neuroscience	Rome, Italy	Researcher (Fixed-term contract)	2006	2017
Istituto Superiore di Sanità	Research Coordination and Support Service	Rome, Italy	Researcher (Permanent position)	2018	2045

Other awards and honors

2005 Fellowship of the It. Soc. of Pharmacology 2007 ▇. ▇▇▇▇▇▇ Med. Res. Inst Preceptor Award

2010 Italian research grant award for Young Investigators 2008 2013-2015 IBANGS Award Committee Member

2013 Fellowship of the Royal Society of Edinburgh, Int. Ex. Prog. 2013-2016 IBANGS Executive Committee

2014 Letter of encomium of the President of ISS for the activities on ASD

2018 Mention of Honor - Research Sector - 100 Italian Excellences Award, Palazzo Montecitorio, Rome

Other CV informations

111 International Peer-reviewed Publications and 7 book chapters

- Coordinator of the National Autism Observatory (▇▇▇▇▇://▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇.▇▇)

- Coordinator of the Italian Network for early detection of ASD (▇▇▇▇▇://▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇.▇▇/▇▇▇▇)

Selected peer-reviewed publications of the PI valid for minimum expertise level
Title	Type	Pag	Vol	Year	DOI	PMID	Cit.**	P.*
Automatic newborn cry analysis: A Non- invasive tool to help autism early diagnosis	Annual International Conference of the IEEE Engineering in Medicine and Biology Society	2953- 2956	-	2012	10.1109/EMBC.2012.63 46583	23366544	32	L
Neurobiology of autism	Article	1-4	251	2013	10.1016/j.bbr.2013.06.01 4	23777647	3	L
Advanced tools for clinical diagnosis of autism spectrum disorders	Conference paper	256-259	42	2014	10.1007/978-3-319- 03005-0_65	-	3	L
Characterization of Neonatal Vocal and Motor Repertoire of Reelin Mutant Mice	Article	1-12	8	2013	10.1371/journal.pone.00 64407	23700474	31	L

Title	Type	Pag	Vol	Year	DOI	PMID	Cit.**	P.*
Reduced social interaction, behavioural flexibility and BDNF signalling in the BTBR T+tf/J strain, a mouse model of autism	Article	35-40	251	2013	10.1016/j.bbr.2012.12.02 8	23270976	79	F
Behavioural methods used in rodent models of autism spectrum disorders: Current standards and new developments	Review	5-17	251	2013	10.1016/j.bbr.2013.05.04 7	23769995	126	L
Mapping pathological phenotypes in reelin mutant mice	Article	95	2	2014	10.3389/fped.2014.0009 5	25237666	21	L
Cry, baby, cry: Expression of distress as a biomarker and modulator in autism spectrum disorder	Article	498-503	20	2017	10.1093/ijnp/pyx014	28204487	40	L
The Knockout of Synapsin II in Mice Impairs Social Behavior and Functional Connectivity Generating an ASD-like Phenotype	Article	5014- 5023	27	2017	10.1093/cercor/bhx207	28922833	22	L
Antenatal ultrasound value in risk calculation for Autism Spectrum Disorder: A systematic review to support future research	Review	83-92	92	2018	10.1016/j.neubiorev.201 8.05.016	29778739	4	L
Early motor signs of attention-deficit hyperactivity disorder: a systematic review	Review	903-916	29	2020	10.1007/s00787-019- 01298-5	30798414	16	L
Quantifying ultrasonic mouse vocalizations using acoustic analysis in a supervised statistical machine learning framework	Article	1-10	9	2019	10.1038/s41598-019- 44221-3	31147563	13	L
Movidea: A software package for automatic video analysis of movements in infants at risk for neurodevelopmental disorders	Article	1-12	10	2020	10.3390/brainsci100402 03	32244544	8	L
Ultrasonic vocalizations as a fundamental tool for early and adult behavioral phenotyping of Autism Spectrum Disorder rodent models	Review	31-43	116	2020	10.1016/j.neubiorev.202 0.06.011	32544538	9	L
Early behavioral markers for neurodevelopmental disorders in the first 3 years of life: An overview of systematic reviews	Review	183-201	116	2020	10.1016/j.neubiorev.202 0.06.027	32610179	10	L
Early motor development predicts clinical outcomes of siblings at high-risk for autism: Insight from an innovative motion-tracking technology	Article	▇▇▇	▇▇	▇▇▇▇	10.3390/brainsci100603 79	32560198	6	L
Early developmental trajectories of expressive vocabulary and gesture production in a longitudinal cohort of Italian infants at high-risk for Autism Spectrum Disorder	Article	1421- 1433	14	2021	10.1002/aur.2493	33644995	3	L
Intervention Services for Autistic Adults: An ASDEU Study of Autistic Adults, Carers, and Professionals Experiences	Article	1623- 1639	52	2021	10.1007/s10803-021- 05038-0	33966137	1	C
Autistic Adult Health and Professional Perceptions of It: Evidence From the ASDEU Project	Article	614102	12	2021	10.3389/fpsyt.2021.6141 02	34122158	1	C
Real-World Experiences in Autistic Adult Diagnostic Services and Post-diagnostic Support and Alignment with Services Guidelines: Results from the ASDEU Study	Article	4129- 4146	51	2021	10.1007/s10803-021- 04873-5	33502713	6	F

* Position: F=First L=Last C=Correspondent O=Other N=Not applicable

** Autocertificated

Selected peer-reviewed publications of the PI for the evaluation CV
Title	Type	Pag	Vol	Year	DOI	PMID	Cit.**
Reduced excitatory neurotransmission and mild Autism-Relevant phenotypes in adolescent shank3 null mutant mice	Article	6525- 6541	32	2012	10.1523/JNEUROSCI.61 07-11.2012	22573675	180
Neuroimaging Evidence of Major Morpho- Anatomical and Functional Abnormalities in the BTBR T+TF/J Mouse Model of Autism	Article	NOT_FO UND	8	2013	10.1371/journal.pone.00 76655	24146902	54
Reduced social interaction, behavioural flexibility and BDNF signalling in the BTBR T+tf/J strain, a mouse model of autism	Article	35-40	251	2013	10.1016/j.bbr.2012.12.02 8	23270976	71
Behavioural methods used in rodent models of autism spectrum disorders: Current standards and new developments	Review	5-17	251	2013	10.1016/j.bbr.2013.05.04 7	23769995	107
Chronic and acute intranasal oxytocin produce divergent social effects in mice	Article	1102- 1114	39	2014	10.1038/npp.2013.310	24190025	116
Difference in Visual Social Predispositions between Newborns at Low-and High-risk for Autism	Article	1-9	6	2016	10.1038/srep26395	27198160	31
Cry, baby, cry: Expression of distress as a biomarker and modulator in autism spectrum disorder	Article	498-503	20	2017	10.1093/ijnp/pyx014	28204487	27
Altered neocortical gene expression, brain overgrowth and functional over-connectivity in chd8 haploinsufficient mice	Article	2192- 2206	28	2018	10.1093/cercor/bhy058	29668850	42
Prevalence of Autism Spectrum Disorder in a large Italian catchment area: A school-based population study within the ASDEU project	Article	1-10	6	2018	10.1017/S20457960180 00483	30187843	49
Automated pose estimation captures key aspects of General Movements at eight to 17 weeks from conventional videos	Article	1817- 1824	108	2019	10.1111/apa.14781	30883894	21

** Autocertificated

Grant
Funded by Institution	Researcher inst. where ▇▇▇▇▇ is/was performed	Year	Title	Position in Projects	Fund (euro)	Source website grant listed
Italian Telecom Foundation Project	Istituto Superiore di Sanità	2019	Smart@pp 2.0: early screening for language delays and neurodevelopmental disorders	Coordinator	200.000,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇ ▇▇▇▇▇.▇▇/▇▇▇▇▇▇▇▇/▇▇▇▇▇ sione- sociale/smartpp-20
Ministry of Health	Istituto Superiore di Sanità	2010	Young Investigator Research Grant - Non invasive tools for early detection of Autism Spectrum Disorders	Coordinator	584.000,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇.▇▇ ▇.▇▇/▇▇▇▇▇▇▇/▇▇▇▇▇▇▇▇/▇ 4_10_1_1_atti_1_1.js p?lingua=italiano&id =51

Funded by Institution	Researcher inst. where ▇▇▇▇▇ is/was performed	Year	Title	Position in Projects	Fund (euro)	Source website grant listed
Italian Ministry of Health - CCM Network	Istituto Superiore di Sanità	2016- 2018	Italian Network for early detection of Autism Spectrum Disorders	Coordinator	441.000,00	▇▇▇▇▇://▇▇▇.▇▇▇- ▇▇▇▇▇▇▇.▇▇/▇▇▇▇▇▇▇▇.▇▇ p?id=programmi/201 2/network-italiano- NIDA&idP=740
▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇- ▇▇▇▇▇ Actions	Istituto Superiore di Sanità	2015- 2018	Integrated view on disruptions of early brain development	Collaborator	256.000,00	▇▇▇▇▇://▇▇▇▇▇▇.▇▇▇▇▇▇. eu/project/id/642996
Italian Ministry of Health	Istituto Superiore di Sanità	2016	Italian Autism Spectrum Disorders Network: filling the gaps in the National Health System care	Coordinator	2.193.112,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇.▇▇ ▇.▇▇/▇▇▇▇/▇_▇▇_▇▇▇▇▇ eAree_4357_listaFile _itemName_18_file.p df
Italian Ministry of Health	Istituto Superiore di Sanità	2018- 2023	National guidelines and governmental clinical/educational activities for people with Autism Spectrum Disorder and their families - Autism Funding - Decreto Ministeriale 30.12.2016 and Legge di Stabilità 2016	Coordinator	50.000.000,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇ ▇▇.▇▇▇▇▇▇.▇▇▇.▇▇/▇▇▇ me/renderNormsanP df?anno=2016&codL eg=68691&parte=1% 20&serie=null
▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇- ▇▇▇▇▇ Actions	Istituto Superiore di Sanità	2019- 2023	Shaping the social brain through early interactions	Collaborator	239.899,00	▇▇▇▇▇://▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇.▇▇/

2.3 CO-PI Profile

Last Name: ▇▇▇▇▇▇▇▇

First Name: ▇▇▇▇▇▇▇▇

Last name at birth: ▇▇▇▇▇▇▇▇

Gender: M

Title: Co-PI: biostatistical analysis of data collected by the BABY@NET surveillance protocol

Nationality: italiana

Date of birth: 17/12/1962

Official H index (Scopus or Web of Science): 50.0

Country of residence: ITALY Country of Birth: ITALY Place of Birth: rieti

Scopus Author Id:7005258334 ORCID ID:0000-0002-0805-2927 RESEARCH ID:C-6480-2016

Contact address

Current organisation name: Istituto Superiore di Sanita'

Current Department / Faculty / Institute / Laboratory name: Research Coordination and Support Service

Street: ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇

Postcode / Cedex: 00161 Town: roma

Phone:▇▇▇▇▇▇▇▇▇▇▇▇▇ Phone 2:

Education / training
Educational institution and location	Degree	Field of study	From year	To year
La Sapienza University, Rome, Italy	Single-cycle master's degree / Laurea magistrale a ciclo unico	Statistics & Probability	1981	1986

Personal Statement:

Dr. ▇▇▇▇▇▇▇▇ is a statistician-epidemiologist with more than 30 years of experience in statistical analysis, infectious diseases epidemiology, surveillance and public health. Since 2013, he is the head of the Epidemiology, Mathematical Models and Biostatistics unit of the department of Infectious Diseases at the Istituto Superiore di Sanità (ISS) and he is involved in several surveillance and project activities related to infectious diseases. On behalf of the Italian Ministry of Health, he is currently the responsible of the Italian national surveillance of Covid-19. Since 2017, he is supervisor of EPIET/ECDC fellowship.

Dr ▇▇▇▇▇▇▇▇ will perform the bioinformatic analysis of clinical/experimental data collected by the BABY@NET surveillance protocol searching for predictive risk factors.

Positions and honors

Positions
Institution	Division / Research group	Location	Position	From year	To year
Istituto Superiore di Sanità	Laboratorio di Epidemiologia e Biostatistica	Rome	Fixed-term Researcher	1988	1990
Istituto Superiore di Sanità	Laboratorio di Epidemiologia e Biostatistica	Rome	Scholarship	1990	▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇	▇▇▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇	▇▇▇▇▇▇▇▇▇, ▇▇, ▇▇▇	Scholarship	1992	1992
Istituto Superiore di Sanità	Laboratorio di Epidemiologia e Biostatistica	Rome	Researcher, permanent position	1993	1997
Istituto Superiore di Sanità	Laboratorio di Epidemiologia e Biostatistica	Rome	Senior Researcher, permanent position	1997	2003
Regione Lazio	Agenzia di Sanità Pubblica	Rome	Public health manager	2003	2013
Istituto Superiore di Sanità	Dipartimento Malattie infettive	Rome	Senior Researcher, permanent position, Head of Epidemiology, Mathematical Models & Biostatistics unit	2013	2022

Other awards and honors

Winner Scholarship HIV-ISS-Italia, 1990 Winner Scholarship HIV-ISS-Estero, 1992

Winner of a Researcher position - Istituto Superiore di Sanità, 1992 Winner of a Senior Researcher position - Istituto Superiore di Sanità, 1992

Winner as Public Health Manager - Unit: Metodi Statistici in Epidemiologia - Area: Laziosanità, 2010 Eligibility for the position Director of Research, Istituto Superiore di Sanità, 2004

Commendation letter - Working group Influenza A/H1N1 pandemic, Laziosanità - 2010

Other CV informations

- Co-chair of the National Surveillance System COVID-19 (Presidency of the Council of Ministers, Civil Protection Department. Ocdpc No. 640 of February 27, 2020)

- Answers to written and oral parliamentary questions

- Support in writing circular notes from the Italian Ministry of Health related to surveillance and control for Infectious Diseases

Selected peer-reviewed publications of the Co-PI valid for minimum expertise level
Title	Type	Pag	Vol	Year	DOI	PMID	Cit.**	P.*
Risk of SARS-CoV-2 infection and subsequent hospital admission and death at different time intervals since first dose of COVID-19 vaccine administration, Italy, 27 December 2020 to mid- April 2021	Article	1-8	26	2021	10.2807/1560- 7917.ES.2021.26.25.210	34169819	8	C
A large food-borne outbreak of campylobacteriosis in kindergartens and primary schools in Pescara, Italy, May-June 2018	Article	1-9	70	2021	10.1099/jmm.0.001262	33475480	0	C
Initial impact of SARS-Cov-2 vaccination on healthcare workers in Italy-Update on the 28th of March 2021	Article	4788- 4792	39	2021	10.1016/j.vaccine.2021.0 7.003	34253419	8	C

Title	Type	Pag	Vol	Year	DOI	PMID	Cit.**	P.*
Percentage and determinants of missed HIV testing in pregnancy: A survey of women delivering in the Lazio region, Italy	Article	899-906	26	2014	10.1080/09540121.2013. 861572	24279737	5	C
HIV-Positive Individuals on Antiretroviral Therapy and with Viral Load Suppressed in 12 Infectious Diseases Clinics in Italy: Successes and Disparities in the HIV Continuum of Care	Article	575-582	33	2017	10.1089/aid.2016.0256	28135809	6	L
Reply to letters to the Editor: Bellavite P. Factors that influenced the historical trends of tetanus and diphtheria. Donzelli A, Duca P. More than 70,000 deaths prevented by vaccination against three diseases in about 75 years The estimation seems exaggerated	Reply	5508- 5509	36	2018	10.1016/j.vaccine.2018.0 7.060	30166045	0	F
People diagnosed with HIV and in care in Italy in 2014: results from the second national survey	Article	760-764	30	2018	10.1080/09540121.2017. 1400639	29134815	4	L
Meningococcal C conjugate vaccine effectiveness before and during an outbreak of invasive meningococcal disease due to Neisseria meningitidis serogroup C/cc11, Tuscany, Italy	Article	4222- 4227	36	2018	10.1016/j.vaccine.2018.0 6.002	29895504	13	F
The impact of immunization programs on 10 vaccine preventable diseases in Italy: 1900- 2015	Article	1435- 1443	36	2018	10.1016/j.vaccine.2018.0 1.065	29428176	43	F
Comparison of early childhood vaccination coverage and timeliness between children born to Italian women and those born to foreign women residing in Italy: A multi-centre retrospective cohort study	Article	2179- 2187	37	2019	10.1016/j.vaccine.2019.0 3.023	30902479	2	L
Vaccine preventable invasive bacterial diseases in Italy: A comparison between the national surveillance system and recorded hospitalizations, 2007-2016	Article	41-48	37	2019	10.1016/j.vaccine.2018.1 1.047	30478004	8	F
Mediterranean spotted fever rickettsiosis in Italy, 2001-2015: Spatio-temporal distribution based on hospitalization records	Article	43-50	10	2019	10.1016/j.ttbdis.2018.09. 001	30197269	12	L
HIV prevalence among adults in Rome: Results of the MeDi (measuring health disparities in HIV prevention) survey. Part 2	Article	30-37	56	2020	10.4415/ANN_20_01_06	32242533	0	L
Prevalence and attitudes to HIV testing among adults visiting public outpatient clinics in Rome: results of the MeDi (Measuring health Disparities in HIV prevention) survey. Part 1	Article	19-29	56	2020	10.4415/ANN_20_01_05	32242532	1	L
Epidemiological characteristics of COVID-19 cases and estimates of the reproductive numbers 1 month into the epidemic, Italy, 28 January to 31 March 2020	Article	1-11	25	2020	10.2807/1560- 7917.ES.2020.25.49.200	33303064	52	L
COVID-19 Disease Severity Risk Factors for Pediatric Patients in Italy	Article	1-10	146	2020	10.1542/peds.2020- 009399	32665373	73	L
Estimating averted COVID-19 cases, hospitalisations, intensive care unit admissions and deaths by COVID-19 vaccination, Italy, january-september 2021	Article	1-8	26	2021	10.2807/1560- 7917.ES.2021.26.47.210	34823637	1	L

Title	Type	Pag	Vol	Year	DOI	PMID	Cit.**	P.*
Pediatric COVID-19 cases prelockdown and postlockdown in Italy	Article	1-4	147	2021	10.1542/peds.2020- 035238	33154154	3	L
Effectiveness of mRNA vaccines and waning of protection against SARS-CoV-2 infection and severe covid-19 during predominant circulation of the delta variant in Italy: Retrospective cohort study	Article	1-10	376	2022	10.1136/bmj-2021- 069052	35144968	1	L
Effectiveness of an mRNA vaccine booster dose against SARS-CoV-2 infection and severe COVID-19 in persons aged >=60 years and other high-risk groups during predominant circulation of the delta variant in Italy, 19 July to 12 December 2021	Article	-	-	2022	10.1080/14760584.2022. 2064280	35389748	0	L

* Position: F=First L=Last C=Correspondent O=Other N=Not applicable

** Autocertificated

Grant
Funded by Institution	Researcher inst. where ▇▇▇▇▇ is/was performed	Year	Title	Position in Projects	Fund (euro)	Source website grant listed
Istituto Superiore di Sanità	Dipartimento di Malattie Infettive, Parassitarie ed Immunomediate	2014	Monitorare la fiducia del pubblico nei programmi vaccinali e le sue necessità informative sviluppando un sistema di decisione assistita per le vaccinazioni tramite il sito "▇▇▇▇▇▇▇▇▇▇.▇▇▇" e altri siti e social network specificatamente dedicati alle vaccinazioni. CCM 2014	Collaborator	45.000,00	▇▇▇▇▇://▇▇▇.▇▇▇- ▇▇▇▇▇▇▇.▇▇/▇▇▇▇▇▇▇▇.▇▇ p?id=node/1884&idP =740
Ministero della Salute	Istituto Superiore di Sanità	2013	Seroprevalence of Hepatitis E virus infection in Italian blood donors: a survey at national and regional level (RF-2013-02354874)	Collaborator	333.384,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇.▇▇ ▇.▇▇/▇▇▇▇/▇_▇▇_▇▇▇▇▇ eAree_4357_listaFile _itemName_21_file.p df
European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n° 602051	Istituto Superiore di Sanità, Rome. Italy	2013- 2017	Grant FP7/HEALTH: HERACLES (Human cystic Echinococcosis ReseArch in CentraL Eastern Societies)	Collaborator	3.879.712,00	▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇- ▇▇▇.▇▇ grant agreement 602051

2.3 Research Collaborators n. 2

Last Name: Mosca

First Name: ▇▇▇▇▇

Last name at birth:

Gender: M

Title: Coordinator of UO2: implementation of the surveillance program in the NICUs and related follow-up services

Nationality: italia

Date of birth: 05/08/1955

Official H index (Scopus or Web of Science): 47.0

Country of residence: ITALY Country of Birth: ITALY Place of Birth: milano

Scopus Author Id:7102054478 ORCID ID:0000-0001-6477-0299 RESEARCH ID:C-5826-2017

Contact address

Current organisation name: Fondazione IRCCS Policlinico Ca' Granda

Current Department / Faculty / Institute / Laboratory name: Neonatology and neonatal Intensive Care Unit

Street: ▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇

Postcode / Cedex: 20122 Town: Milano

Phone:▇▇▇▇▇▇▇▇▇▇▇▇▇ Phone 2: ▇▇▇▇▇▇▇▇▇▇

Education / training
Educational institution and location	Degree	Field of study	From year	To year
University of Milan, Italy	Single-cycle master's degree / Laurea magistrale a ciclo unico	Medicine and Surgery	1974	1980
University of Milan, Italy	Specialization / Specializzazione	Board Certification in Pediatrics	1981	1983
University of Milan, Italy	Specialization / Specializzazione	Board Certification in Neonatology cum Laude	1983	1984
University of Milan, Italy	Specialization / Specializzazione	Board Certification in Neonatal Surgery	1986	1990

Personal Statement:

Our proposal aims to implement a technology-based national surveillance network for the identification of early risk factors for ASD/NDDs in at-risk populations and prevention strategies in the National Health Service. Prof ▇▇▇▇▇ ▇▇▇▇▇ will be responsible for the implementation and coordination of the surveillance program in the NICUs and related follow-up services. His expertise and professional competences are specific for the tasks planned considering his role as Past President of the Italian Society of Neonatology and actual President of the Italian Society of Pediatric Nutrition.

Positions and honors

Positions
Institution	Division / Research group	Location	Position	From year	To year
University of Milan	Department of Clinical Science and Community Health	Milan, Italy	Associate Professor of Pediatrics and Neonatology	2005	2014
National Health	Ministry Health Superior Council	Italy	Expert member	2006	2009
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico	Neonatology and Neonatal Intensive Care Unit	Milan, Italy	Director	2009	2045
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico	Pediatric and Neonatal Area	Milan, Italy	Director	2013	2016
University of Milan	Department of Clinical Sciences and Community Health	Milan, Italy	Full Professor of Pediatrics and Neonatology	2014	2030
University of Milan	Postgraduate Specialization School of Pediatrics	Milan, Italy	Director	2015	2020
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico	Department of Woman, Newborn and Child Health	Milan, Italy	Vice-Director	2017	2018
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico	Department of Woman, Newborn and Child Health	Milan, Italy	Director	2019	2030
Italian Society of Neonatology (SIN)	Italian Society of Neonatology (SIN)	Italy	President	2018	2021
Italian Society of Pediatric Nutrition (SINUPE)	Italian Society of Pediatric Nutrition (SINUPE)	Italy	President	2021	2025

Other awards and honors

▇▇▇▇▇ ▇▇▇▇▇ belongs the Editorial Board of several scientific journals. He received >300 personal invitations to speak at national and international conferences, on radio and television in the last 5 years. He has extensive local and international academic research collaborations. Member of the Italian Pediatric Society, European Society for Pediatrics Research, Past President for the Italian Society of Neonatology and current President for the Italian Society of Pediatric Nutrition.

Grant
Funded by Institution	Researcher inst. where ▇▇▇▇▇ is/was performed	Year	Title	Position in Projects	Fund (euro)	Source website grant listed
Ministero della Salute and Heinz Italia SPA	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano	2016	The potential of fermented functional food-based immunonutritional strategy against neonatal sepsis	Coordinator	450.000,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇.▇▇ ▇.▇▇/▇▇▇▇▇▇▇/▇▇▇▇/▇▇_▇ _ricerca.html

2.4 Research Collaborators n. 3

Last Name: ▇▇▇▇▇▇▇▇▇

First Name: ▇▇▇▇▇▇

Last name at birth:

Gender: F

Title: Research collaborator: enrollment of preterms/SGA and responsible for the epigenetic analysis

Nationality: Italiana

Date of birth: 18/03/1969

Official H index (Scopus or Web of Science): 27.0

Country of residence: ITALY Country of Birth: ITALY Place of Birth: Monza

Scopus Author Id:7006130248 ORCID ID:0000-0002-0186-0710 RESEARCH ID:K-6717-2016

Contact address

Current organisation name: Fondazione IRCCS Policlinico Ca' Granda

Current Department / Faculty / Institute / Laboratory name: Neonatology and neonatal Intensive Care Unit

Street: ▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇

Postcode / Cedex: 20122 Town: Milano

Phone:▇▇▇▇▇▇▇▇▇▇▇▇▇ Phone 2: ▇▇▇▇▇▇▇▇▇▇

Education / training
Educational institution and location	Degree	Field of study	From year	To year
University of Milan, Italy	Single-cycle master's degree / Laurea magistrale a ciclo unico	Medicine and Surgery	1989	1995
University of Milan, Italy	Specialization / Specializzazione	Pediatrics	1995	1999
University of Maastricht	PhD	The vulnerability of the preterm brain: insights into pathogenesis and neuroimaging	2017	2019

Personal Statement:

Our proposal aims to implement a technology-based national surveillance network for the identification of early risk factors for ASD/NDDs in at-risk populations and prevention strategies in the National Health Service. ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ will coordinate the enrollment of prematurely born infants by Fondazione IRCCS Ca' Granda and will be responsible for the epigenetic analysis in collaboration with the laboratory of Genome Biology Unit, INGM, Milan directed by ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇. Her professional competences are specific for the tasks planned in the present application: she is a senior neonatologist and researcher in neonatal neurology and neuroimaging and more recently she has addressed her research to human behavioral epigenetics applied to neonatal research.

Positions and honors

Positions
Institution	Division / Research group	Location	Position	From year	To year
A.O. Istituti Clinici di Perfezionamento	Neonatal Intensive Care Unit	Milan - Italy	Consultant Neonatologist	2000	2005
University of Milan	Department of Clinical Sciences and Community Health	Milan - Italy	Fixed-term Researcher (RTD-B)	2017	2020
The ▇▇▇▇▇▇▇ ▇▇▇▇▇ Center	Department of Neonatology	Copenhagen (Denmark)	Research Fellow	2002	2002
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano	Neonatal Intensive Care Unit	Milan - Italy	Consultant Neonatologist	2005	2045
University of Milan	Department of Clinical Sciences and Community Health	Milan - Italy	Fixed-term Researcher (RTD-A)	2013	2016
Italian Society of Neonatology (SIN)	Working Group of Neurology and Follow-up of the Italian Society of Neonatology	Italy	Secretary	2019	2022
University of Milan	Department of Clinical Sciences and Community Health	Milan - Italy	Associate Professor of Pediatrics	2020	2045

Other awards and honors

2001 Medical Residency Fellowship in Neonatology: ▇. ▇▇▇▇▇▇▇▇▇▇, Varese

2002 European Society for Pediatric Research Grant: Young Investigators Exchange Programme

Grant
Funded by Institution	Researcher inst. where ▇▇▇▇▇ is/was performed	Year	Title	Position in Projects	Fund (euro)	Source website grant listed
European Union under	Fondazione IRCCS Ca Granda	2014-	An optical neuro-monitor of	Collaborator	206.000,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇-
the Competitiveness	Ospedale Maggiore Policlinico	2017	cerebral oxygen metabolism			▇▇▇▇▇▇▇.▇▇/▇▇▇▇▇/▇▇▇▇
and Innovation			and blood flow for			view/
Framework			neonatology - BabyLux
Programme 2007-
2013 - Grant
▇▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇
Bando Ricerca	Fondazione IRCCS Ca Granda	2019	Project 20-weeks-	Collaborator	90.000,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇.▇▇
Finalizzata 2019	Ospedale Maggiore Policlinico		18Months: the impact of			▇.▇▇/▇▇▇▇▇▇▇/▇▇▇▇.▇▇▇
			maternal depression and			l
			immuno-inflammation on
			foetus brain growth and
			infant neurodevelopment. A
			longitudinal imaging-
			epigenetic study

Funded by Institution	Researcher inst. where ▇▇▇▇▇ is/was performed	Year	Title	Position in Projects	Fund (euro)	Source website grant listed
Bando Fondazione	Fondazione IRCCS Ca Granda	2019	The impact of Maternal	Collaborator	174.300,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇
CARIPLO	Ospedale Maggiore Policlinico		Anxiety-DEpression and			▇▇▇▇▇▇▇▇▇.▇▇/▇▇/▇▇▇▇▇▇▇▇/
			ImmuNo-inflammation on			progetti.html
			FoetusbrAin growth and
			infant neurodevelopment:
			An iMaging.epigenetic
			Longitudinal studY (MADE
			IN FAMILY)

2.5 Research Collaborators n. 4

Last Name: ▇▇▇▇▇▇▇

First Name: ▇▇▇▇▇▇▇

Last name at birth:

Gender: M

Title: Coordinator of UO3: supervising and organizing siblings recruitment and testing

Nationality: Italiana

Date of birth: 21/04/1957

Official H index (Scopus or Web of Science): 32.0

Country of residence: ITALY

Country of Birth: ITALY

Place of Birth: Albese con cassano

Scopus Author Id:7003975446 ORCID ID:0000-0001-6268-5883 RESEARCH ID:K-8856-2016

Contact address

Current organisation name: IRCCS Medea

Current Department / Faculty / Institute / Laboratory name: Child Psychopathology Unit

Street: IRCCS ▇▇▇▇▇▇▇ ▇▇▇▇▇

Postcode / Cedex: 23842 Town: Bosisio Parini

Phone:▇▇▇▇▇▇▇▇▇▇▇▇▇ Phone 2:

Education / training
Educational institution and location	Degree	Field of study	From year	To year
University of Milan, Milan, Italy	Single-cycle master's degree / Laurea magistrale a ciclo unico	Medicine and Surgery	1976	1982
University of Milan, Milan, Italy	Specialization / Specializzazione	Professional qualification in Child and Adolescent psychiatry	1983	▇▇▇▇
▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ - ▇▇▇▇▇▇▇▇▇ (▇▇▇▇)	Master's Degree / Laurea Magistrale	Healthcare Management	1998	1998
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇, Milan, Italy	Master's Degree / Laurea Magistrale	Healthcare Organization and Management	1999	2000
Cerismas - Milan	Specialization / Specializzazione	Advanced Course in Healthcare project manager	2010	2010

Personal Statement:

Our proposal aims to implement a technology-based national surveillance network for the identification of early risk factors for ASD/NDDs in at-risk populations and prevention strategies in the National Health Service. Dr ▇▇▇▇▇▇▇ is a Medical Director at La Nostra Famiglia and Head of Developmental Psychopathology Unit at IRCCS Medea with extensive clinical and research experience. As a health manager, he has special expertise in all organizational aspects of health care. He has been the head of several international and national projects on neurodevelopmental disorders both at the biomedical and at the clinical level. In the present project, he will work supervising and organizing procedures for child recruitment and testing, as well as for assessing prevention protocols.

Positions and honors

Positions
Institution	Division / Research group	Location	Position	From year	To year
Scientific Institute IRCCS Medea	Clinical Unit - Diagnosis and tools	▇▇▇▇▇▇▇ ▇▇▇▇▇▇ (LC) - Italy	Medical Doctor coordinator	1993	1997
Vita-Salute San ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇	Faculty of Psychology	Milan (Italy)	Professor	2007	2012
University of Milan	Faculty of Medicine and Surgery - School for TNPEE (Terapista della Neuropsicomotricità dell'Età Evolutiva)	Milan (Italy)	Tenured Professor	2008	2016
Scientific Institute IRCCS Medea	Hospital for Rehabilitation and Outpatient Rehabilitation in Developmental age	▇▇▇▇▇▇▇ ▇▇▇▇▇▇ (LC) - Italy	Medical Director (at regional level)	1998	2017
University of Milan	Faculty of Medicine and Surgery, Residency in Child and Adolescent Neuropsychiatry	Milan (Italy)	Adjunct Professor	2003	2030
Scientific Institute IRCCS Medea	Child Psychopathology Department	▇▇▇▇▇▇▇ ▇▇▇▇▇▇ (LC) - Italy	Head of the clinical and research unit	2017	2030
Scientific Institute IRCCS Medea	Hospital for Rehabilitation in Developmental age	▇▇▇▇▇▇▇ ▇▇▇▇▇▇ (LC) - Italy	Chief Medical Officer (at national level)	2017	2030

Other awards and honors

Recipient of several national and international grants as PI and Co-PI, funded by the FP6-NEST Project ("TACT" Thought in ACTion), Italian Ministry of Health (Ricerca Corrente, Finalizzata, Strategica, CCM), Lombardy Region, ▇▇▇ ▇▇▇▇▇, Fondazione Cariplo. Member of the IRCCS ▇▇▇▇▇▇▇ ▇▇▇▇▇ Ethical committee, member of public commissions concerning autism and neurodevelopmental disorders in Lombardy and ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ regions, member of the panel of experts on the National Guidelines on autism.

Grant
Funded by Institution	Researcher inst. where ▇▇▇▇▇ is/was performed	Year	Title	Position in Projects	Fund (euro)	Source website grant listed
Italian Ministry of Health (RF-2001-3-01)	IRCCS E. MEDEA	2001	Prevalenza dei disturbi mentali in una popolazione urbana di preadolescenti e associazione tra assetto genetico e comportamento	Coordinator	25.151.451,00	▇▇▇▇▇://▇▇▇▇▇▇.▇▇/▇▇▇▇▇ io_stampa/files/prism a_2.pd
UE-2003-3-01	IRCCS E. MEDEA	2003	Thought in action - TACT	Collaborator	1.999.442,00	▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇ ▇.▇▇/▇▇▇/▇▇▇▇▇▇▇▇/▇▇▇ earch-unit/advanced- robotics-and-human-

Funded by Institution	Researcher inst. where ▇▇▇▇▇ is/was performed	Year	Title	Position in Projects	Fund (euro)	Source website grant listed
Italian Ministry of Health (RF-2007-3-01)	IRCCS E. MEDEA	2007	La salute mentale nel bambino e nell'adolescente: dai fattori di rischio biologico e psicosociale, agli indicatori precoci e di carico familiare, per lo sviluppo di modelli di prevenzione ed intervento evidence-based dei disturbi mentali gravi	Coordinator	2.000.000,00	▇▇▇▇▇://▇▇▇▇▇▇.▇▇/▇▇▇ sletter/spedizioni/101 0_n03.htm#proSalut eM
CCM-2011-3-01	IRCCS E. MEDEA	2011	Communication Disorders: reducing health inequalities	Coordinator	133.000,00	▇▇▇▇▇://▇▇▇.▇▇▇- ▇▇▇▇▇▇▇.▇▇/▇▇▇▇▇▇▇▇.▇▇ p?id=programmi/201 1/disturbi-del- linguaggio&idP=740
CCM-2012-3-01	IRCCS E. MEDEA	2012	Network Italiano per il riconoscimento precoce dei Disturbi dello Spettro Autistico (NIDA)	Collaborator	441.000,00	▇▇▇▇▇://▇▇▇.▇▇▇- ▇▇▇▇▇▇▇.▇▇/▇▇▇▇▇▇▇▇.▇▇ p?id=programmi/201 2/network-italiano- NIDA&idP=740
A-Altre-2012-3-01	IRCCS E. MEDEA	2012	L'évaluation d'une intervention ciblée sur les habiletés socials auprès de trés jeunes enfants atteints de troubles du spectre de l'autisme - Very young children with autism spectrum disorders: evaluation of an intervention on social skills	Collaborator	220.704,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇.▇▇/▇ aress/catalogue-des- recherches/detail/▇▇▇ ▇▇▇▇▇▇▇▇-dune- intervention-ciblee- sur-les-habiletes- sociales-aupres-de- tres-jeunes-enfants- atteints-de-troubles- du-spectre-de- lautisme-
Italian Ministry of Health RF-RETE- 2013-A2-01	IRCCS E. MEDEA	2013	Italian Autism spectrum Disorders network: filling the gaps in the national helth system	Collaborator	2.193.112,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇.▇▇ ▇.▇▇/▇▇▇▇▇▇▇/▇▇▇▇▇▇▇▇/▇ ocumenti/provvedim entiDirigenti/DGRIC_ accordi_stipulati.pdf
A-CassaRispCuneo - 2013 - A2-01	IRCCS E. MEDEA	2013	Validazione di un protocollo sostenibile di intervento precoce per l'Autismo - PROSA	Collaborator	100.000,00	▇▇▇▇▇://▇▇▇▇▇▇.▇▇/▇▇▇▇ rca/ric_altri_enti/ricer che_realizzate_con_ altri_enti_associazion i_2015.pdf
CARIPLO-2017-A3-01	IRCCS E. MEDEA	2017	AUTITEC: Soluzioni Tecnologiche per l'Autismo (2017-2293)	Coordinator	88.000,00	▇▇▇▇▇://▇▇▇▇▇.▇▇/▇▇▇▇▇/ wp- content/uploads/202 0/06/Scheda- Progetto-AUTITEC- per-sito-ASPHI.pdf
TIM_2019_A2_01	IRCCS E. MEDEA	2019	5A - Autonomie per l'Autismo Attraverso realtà virtuale, realtà Aumentata e Agenti conversazionali	Collaborator	250.000,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇ ▇▇▇▇▇.▇▇/▇▇▇▇▇▇▇/▇▇▇▇▇▇- di-comunicare- vincitori-2020

2.6 Research Collaborators n. 5

Last Name: ▇▇▇▇▇▇▇▇▇

First Name: ▇▇▇▇▇▇▇

Last name at birth:

Gender: F

Title: Coordinator of UO4: recruitment and clinical/experimental evaluation of infants/children enrolled in the project, biological sampling and metabolomic analysis

Nationality: italiana

Date of birth: 10/06/1968

Official H index (Scopus or Web of Science): 27.0

Country of residence: ITALY Country of Birth: ITALY Place of Birth: napoli

Scopus Author Id:6603209429 ORCID ID:0000-0002-6025-2870 RESEARCH ID:AAB-9598-2022

Contact address

Current organisation name: Azienda Ospedaliera Universitaria ▇▇▇▇▇▇▇▇ ▇▇, Regione Campania

Current Department / Faculty / Institute / Laboratory name: Department of Maternal-Infantile - Child and Adolescent

Neuropsychiatry Unit

Street: via ▇▇▇▇▇▇▇

Postcode / Cedex: 80131 Town: napoli

Phone:▇▇▇▇▇▇▇▇▇▇▇▇▇ Phone 2:

Education / training
Educational institution and location	Degree	Field of study	From year	To year
School of Medicine, University of Naples, Italy	Single-cycle master's degree / Laurea magistrale a ciclo unico	Medicine and surgery	1986	1992
School of Medicine and Surgery, Second University of Naples, Italy	Specialization / Specializzazione	Child Neuropsychiatry	1992	1997
University of ▇▇▇▇▇▇▇▇ ▇▇ Naples	PhD	Neuropsychopathology of learning processes in children	1997	2000

Personal Statement:

The main goal of the project will be to implement a technology-based national surveillance network for the identification of early risk factors for ASD/NDDs in at-risk populations and prevention strategies in the National Health Service. The clinical unit coordinated by Dr. ▇▇▇▇▇▇▇▇▇ cares for more than 500 patients with developmental psychiatric disorders each year.

Specifically, she will be responsible for the recruitment and clinical/experimental evaluation of infants/children enrolled in the project and biological sampling. In addition, she will contribute to the interpretation and processing of clinical/experimental data and outcomes, as well as to the study dissemination process.

Positions and honors

Positions
Institution	Division / Research group	Location	Position	From year	To year
Second University of Naples	Department of Child Neuropsychiatry	Naples, Italy	Postdoctoral/Research Fellow	2001	2003
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇	Child Neuropsychiatry at the Department of Pediatrics	Naples, Italy	Researcher	2006	2011
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇	Child Neuropsychiatry, Department of Pediatrics	Naples, Italy	Associate Professor	2011	2045
AOU ▇▇▇▇▇▇▇▇ ▇▇	UOSD Child Neuropsychiatry	Naples, Italy	Responsible UOSD	2018	2045
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇	School Child Neuropsychiatry	Naples, Italy	Director	2018	2045

Other awards and honors

Cozzarelli Price for the paper: Biological Sciences: Genetics: A Genetic Variant that Disrupts METTranscription Is Associated with Autism. Proc Natl Acad Sci U S A. 2006

Grant
Funded by Institution	Researcher inst. where ▇▇▇▇▇ is/was performed	Year	Title	Position in Projects	Fund (euro)	Source website grant listed
FONDAZIONE ▇▇▇	▇▇▇▇ NEUROPSICHIATRIA INFANTILE - ▇▇▇▇▇▇▇▇ ▇	2022- 2023	e-PediatricChronic Care (ePCC) - La tecnologia digitale al servizio del paziente pediatrico affetto da patologia cronica	Coordinator	50.000,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇ ▇▇▇▇▇.▇▇/▇▇▇▇▇▇▇▇/▇▇▇▇▇▇ ione-e-ricerca- scientifica/e- pediatricchronic-care
PNRR M4C2 relative ai Centri Nazionali	UOSD NEUROPSICHIATRIA INFANTILE - ▇▇▇▇▇▇▇▇ ▇▇	2022	Overcoming the limits of gene therapy for treating hereditary neurodegenerative diseases: the sphingolipidoses mode	Collaborator	150.000,00	▇▇▇▇▇://▇▇▇.▇▇▇.▇▇▇. it/it/
ISS-NIDA 2	UOSD NEUROPSICHIATRIA INFANTILE - ▇▇▇▇▇▇▇▇ ▇▇	2021	Implementazione di una rete per l'individuazione precoce di soggetti con autismo nella regione campania	Coordinator	54.574,00	▇▇▇▇▇://▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇.▇▇ /
JANSSEN_Esketinsui	UOSD NEUROPSICHIATRIA INFANTILE - ▇▇▇▇▇▇▇▇ ▇▇	2019- 2022	Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation	Collaborator	413.434,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇. com/

Funded by Institution	Researcher inst. where ▇▇▇▇▇ is/was performed	Year	Title	Position in Projects	Fund (euro)	Source website grant listed
Ist. Servier IRIS	UOSD NEUROPSICHIATRIA INFANTILE - ▇▇▇▇▇▇▇▇ ▇▇	2019- 2021	Efficacy and safety of bumetanide oral liquid formulation in children and adolesents aged from 7 to less than 18 years old with Autism Spectrum Disorder	Collaborator	96.000,00	▇▇▇▇▇://▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇.▇▇▇/▇▇▇▇▇▇▇▇/▇ nstitut-de- recherches- internationales- servier-iris-sarl/
ISS-NIDA 1	UOSD NEUROPSICHIATRIA INFANTILE - ▇▇▇▇▇▇▇▇ ▇▇	2019- 2020	Implementazione di una rete per l'individuazione precoce di soggetti con autismo nella regione campania	Coordinator	50.000,00	▇▇▇▇▇://▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇.▇▇ /
Sa_Document_s.r.l	UOSD NEUROPSICHIATRIA INFANTILE - ▇▇▇▇▇▇▇▇ ▇▇	2018- 2019	Training intervento precoce mediato dai genitori per i disturbi della comunicazione e relazione	Coordinator	10.000,00	-
ICON	UOSD NEUROPSICHIATRIA INFANTILE - ▇▇▇▇▇▇▇▇ ▇▇	2018- 2021	ACT_Studio interventistico, randomizzato, in doppio cieco controllato con placebo, principio attivo di confronto (fluoxetina), a dose fissa di vortioxetina in pazienti pediatrici di età compresa fra 7 e 11 anni con disturbo depressivo maggiore (DDM)	Collaborator	14.482,00	-
Synteract-▇▇▇▇▇▇▇▇	UOSD NEUROPSICHIATRIA INFANTILE - ▇▇▇▇▇▇▇▇ ▇▇	2018- 2020	Studio di fase II multicentrico, randomizzato, a gruppi paralleli, in singolo cieco, per valutare la farmacocinetica e la correlazione PKPD del trazodone dopo dosi orali singole e ripetute, in bambini di età compresa tra 2 e 17 anni, che soffrono di insonnia ed affetti da autismo disabilità intellettiva o disturbo da deficit di attenzione e iperattività (ADHD)	Collaborator	41.940,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇.▇▇▇/
REGIONE CAMPANIA FEASR - Programma di Sviluppo Rurale 2014-2020 MISURA 16 -Cooperazione	UOSD NEUROPSICHIATRIA INFANTILE - ▇▇▇▇▇▇▇▇ ▇▇	2014- 2020	Agrisocial lab	Collaborator	30.000,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇ ▇▇▇▇▇.▇▇/▇▇▇▇▇▇▇▇▇▇▇▇/

2.7 Research Collaborators n. 6 - Under 40

Last Name: ▇▇▇▇

First Name: ▇▇▇▇▇▇▇▇▇

Last name at birth:

Gender: F

Title: Research collaborator: recruitment, clinical/experimental evaluations of at-risk populations

Nationality: Italiana

Date of birth: 04/06/1984

Official H index (Scopus or Web of Science): 9.0

Country of residence: ITALY Country of Birth: ITALY Place of Birth: Lecco

Scopus Author Id:42662123800 ORCID ID:0000-0001-7959-0354 RESEARCH ID:K-1424-2016

Contact address

Current organisation name: IRCCS Medea

Current Department / Faculty / Institute / Laboratory name: Child Psychopathology Unit

Street: ▇▇▇ ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇

Postcode / Cedex: 23842 Town: Bosisio Parini

Phone:▇▇▇▇▇▇▇▇▇▇▇▇▇ Phone 2:

Education / training
Educational institution and location	Degree	Field of study	From year	To year
Vita-Salute San ▇▇▇▇▇▇▇▇, University, Milan, Italy	Bachelor Degree / Laurea Triennale	Psychology	2003	2006
Vita-Salute San ▇▇▇▇▇▇▇▇, University, Milan, Italy	Master's Degree / Laurea Magistrale	Clinical Psychology	2006	2008
Vita-Salute San ▇▇▇▇▇▇▇▇, University, Milan, Italy	PhD	Developmental Psychopathology	2010	2013
Studi Cognitivi, Psychotherapy School, Milan, Italy	Specialization / Specializzazione	Child and Adolescent Psychotherapy and Psychopathology	2014	2014

Personal Statement:

The project deals with essential challenges in the context of neurodevelopmental disorders (mainly ASD) benefiting from longitudinal design in infancy and cutting-edge experimental and telehealth measures. Dr ▇▇▇▇ has extensive expertise in longitudinal infant studies and in both behavioral and neurophysiological studies to test early sensory, language, and social skills in early phases of life. She has expertise in coordinating research projects and teams. Dr ▇▇▇▇ will be a research collaborator for recruitment, set-up of assessments, and clinical and experimental evaluations of at-risk populations.

Positions and honors

Positions
Institution	Division / Research group	Location	Position	From year	To year
Scientific Institute San ▇▇▇▇▇▇▇▇ Hospital	Developmental Psychopathology Unit	Milan, Italy	Clinical Consultant	2012	2015
Institut Universitaire en Santé Mentale de Québec	Clinical and Cognitive Neuroscience Research Axis	Québec, Canada	Visiting Post-Doctoral Researcher	2014	2014
Istituto Scientifico IRCCS E. Medea	Child Psychopathology Unit	▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Lecco, Italy	Fixed-term Researcher	2016	2018
Istituto Scientifico IRCCS E. Medea	Child Psychopathology Unit	▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Lecco, Italy	Permanent Researcher	2018	2045
Vita-Salute San ▇▇▇▇▇▇▇▇, University	Faculty of Psychology	Milan, Italy	Adjunct Professor	2019	2045

Other awards and honors

-2021 PI - Integrated experimental techniques for early identification in autism-5x1000 Italian MoH 48.000 €

-2018 PI - Trajectories of biomarkers in autism-5x1000 Italian MoH 40.000€

-2016 PI - Early identification and trajectories in autism-5x1000 Italian MoH 50.000 €

-2016 ▇▇▇ ▇▇▇▇▇▇▇ Young Investigator Award-AIRA 5.000 €

-2014 Research Award-Fondazione Banca del Monte di Lombardia 12.500 €

Grant
Funded by Institution	Researcher inst. where ▇▇▇▇▇ is/was performed	Year	Title	Position in Projects	Fund (euro)	Source website grant listed
Fondazione Italiana per l'Autismo (FIA), Italy	IRCCS ▇▇▇▇▇▇▇ ▇▇▇▇▇	2022	Biomarkers of early intervention in siblings of children with autism	Coordinator	110.000,00	▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇ ne- ▇▇▇▇▇▇▇.▇▇/▇▇▇▇▇▇▇▇- oggetto-della- raccolta-fondi-2021/

2.8 Research Collaborators n. 7 - Under 40

Last Name: ▇▇▇▇▇▇

First Name: ▇▇▇▇▇▇

Last name at birth:

Gender: M

Title: Research collaborator: recruitment, clinical/experimental evaluations of at-risk populations

Nationality: Italiana

Date of birth: 13/12/1982

Official H index (Scopus or Web of Science): 12.0

Country of residence: ITALY Country of Birth: ITALY Place of Birth: napoli

Scopus Author Id:54397583800 ORCID ID:0000-0001-5704-4483 RESEARCH ID:K-8657-2016

Contact address

Current organisation name: Azienda Ospedaliera Universitaria ▇▇▇▇▇▇▇▇ ▇▇, Regione Campania

Current Department / Faculty / Institute / Laboratory name: ▇▇▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ - ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇▇

▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇

▇▇▇▇▇▇: ▇▇▇ ▇▇▇▇▇▇▇ ▇

Postcode / Cedex: 80123 Town: napoli

Phone:00393492966143 Phone 2:

Education / training
Educational institution and location	Degree	Field of study	From year	To year
School of Medicine, University of Naples, Italy	Master's Degree / Laurea Magistrale	Medicine and Surgery	2000	2006
School of Medicine, University of Naples, Italy	Specialization / Specializzazione	Professional qualification in Child and Adolescent Neuropsychiatry	2007	2012
School of Medicine, University of Naples, Italy	PhD	Behavioural Sciences and Learning Processes	2012	2014

Personal Statement:

The main goal of the project will be to implement a technology-based national surveillance network for the identification of early risk factors for ASD/NDDs in at-risk populations and prevention strategies in the National Health Service. ▇▇▇▇.

▇▇▇▇▇▇ ▇▇▇▇▇▇ is a child neuropsychiatrist trained at the Vanvitelli and ▇▇▇▇▇▇▇▇ ▇▇ Universities in Naples. His main clinical activity is the evaluation and treatment of complex neurodevelopmental disorders (mainly, ADHD and autism spectrum disorders) with various psychiatric comorbidities. His role in the project will be to participate in the recruitment and evaluation of enrolled at-risk children and interpretation of clinical/experimental data.

Positions and honors

Positions
Institution	Division / Research group	Location	Position	From year	To year
King's College London	Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience	London, UK	Visiting Researcher	2014	2015
AORN Santobono-Pausilipon	Child and Adolescent Neuropsychiatry	Naples, Italy	Clinician	2018	2021
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇	Department of Translational Medicine	Naples, Italy	Associate Professor	2021	2045
AOU ▇▇▇▇▇▇▇▇ ▇▇	UOSD Child Neuropsychiatry	Naples, Italy	Clinician	2021	2045

Other awards and honors

- "▇. ▇▇▇▇▇▇▇" award at XXVIII conference of the Italian Society of Social and Preventive Pediatrics for the best communication

- European College of Neuropsychopharmacology Award at XXVII conference of the Italian Society of Child and Adolescent Neuropsychiatry for the best poster

- Award: Highly cited article published in Italian Journal of Pediatrics between May 2017 and May 2018. Italian Society of Pediatricians

-External Expert for the Italian Agency of Drugs (AIFA)

Grant
Funded by Institution	Researcher inst. where ▇▇▇▇▇ is/was performed	Year	Title	Position in Projects	Fund (euro)	Source website grant listed
None	None	0	None	Collaborator	0,00	None

2.9 Additional Research Collaborators n. 2 - Under 40 to hire

Last Name: ▇▇▇▇▇▇▇▇▇

First Name: ▇▇▇▇▇▇▇

Last name at birth:

Gender: M

Title: Processing and immunometric analysis of biological samples

Nationality: Italiana

Date of birth: 04/09/1982

Official H index (Scopus or Web of Science): 16.0

Country of residence: ITALY Country of Birth: ITALY Place of Birth: Tivoli

Scopus Author Id:24492392800 ORCID ID:0000-0001-5001-285X RESEARCH ID:U-4194-2017

Contact address

Current organisation name: Istituto Superiore di Sanita'

Current Department / Faculty / Institute / Laboratory name: Research Coordination and Support Service

Street: ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇

Postcode / Cedex: 00161 Town: Roma

Phone:▇▇▇▇▇▇▇▇▇▇▇▇▇ Phone 2:

Education / training
Educational institution and location	Degree	Field of study	From year	To year
University of Rome "Tor Vergata"	Bachelor Degree / Laurea Triennale	Cellular and Molecular Biology	2001	2005
University of Rome "Tor Vergata"	Master's Degree / Laurea Magistrale	Science specialization in Human Evolution and Biology	2005	2007
University of Rome "▇▇▇ ▇▇▇▇▇▇▇"	PhD	Immunology and Applied Biotechnology	2007	2011
University of Rome "Tor Vergata"	Specialization / Specializzazione	Professional qualification in Biology	2009	2009
University of Rome "La Sapienza"	Specialization / Specializzazione	Professional Master in Phytotherapy in Oncology	2016	2018

Personal Statement:

Our proposal aims to implement a technology-based national surveillance network for the identification of early risk factors for ASD/NDDs in at-risk populations and prevention strategies in the National Health Service. Dr. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ will be recruited ex-novo to provide cellular biology and biochemical procedures and proteomic analyses required for data acquisition and interpretation. Dr. ▇▇▇▇▇▇▇▇▇ gained a good expertise in the field of cellular and molecular biology, and in the last years, he achieved major insights in proteomics and in immunometric analyses on biological samples (e.g., serum, plasma).

Positions and honors

Positions
Institution	Division / Research group	Location	Position	From year	To year
Fondazione Veronesi	None	Milan	Postdoctoral Research Fellow	2020	2022
University of Rome "Tor Vergata"	Settore Parco Scientifico	Rome (Italy)	External consultant	2008	2008
University of Rome "Tor Vergata"	Department of Biology	Rome (Italy)	Research fellow	2012	2013
Istituto Superiore di Sanità	Department of Oncology and Molecular Medicine	Rome (Italy)	PostDoc Research fellow	2014	2016
University of Verona / Istituto Superiore di Sanità	Department of Neurosciences, Biomedicine and Movement Sciences Verona	Verona/Rome (Italy)	PostDoc Research fellow	2016	2016
Campus Bio-Medico University	Depatment of Medicine	Rome (Italy)	Research assistant	2017	2019

Other awards and honors

-Post-doctoral Fellowships Rome - anno 2014 - Fondazione ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ (FUV)

-Post-doctoral Fellowships - anno 2015 - FUV

-Post-doctoral Fellowships - anno 2019 - FUV

-Post-doctoral Fellowships - anno 2020 - FUV

-Post-doctoral Fellowships - anno 2021 - FUV

-Post-doctoral Fellowships - anno 2022 - FUV

-Master award "▇▇▇▇▇▇▇▇▇▇ e ▇▇▇▇ ▇▇▇▇▇" fund, University Tor Vergata, 2008

-ImmunoTools special Award 2014

Grant
Funded by Institution	Researcher inst. where ▇▇▇▇▇ is/was performed	Year	Title	Position in Projects	Fund (euro)	Source website grant listed
None	None	0	None	Collaborator	0,00	None

2.10 Additional Research Collaborators n. 3 - Under 40 to hire

Last Name: ▇▇▇▇▇▇▇

First Name: ▇▇▇▇▇▇

Last name at birth:

Gender: F

Title: Infants recruitment and assessment, data-entry and test scoring

Nationality: Italia

Date of birth: 26/06/1982

Official H index (Scopus or Web of Science): 3.0

Country of residence: ITALY Country of Birth: ITALY Place of Birth: Napoli

Scopus Author Id:56730508800 ORCID ID:0000-0002-0983-5368 RESEARCH ID:AHD-9872-2022

Contact address

Current organisation name: Azienda Ospedaliera Universitaria ▇▇▇▇▇▇▇▇ ▇▇, Regione Campania

Current Department / Faculty / Institute / Laboratory name: Department of Maternal-Infantile - Child and Adolescent

Neuropsychiatry Unit

Street: Via ▇▇▇▇▇▇▇ da Caserta

Postcode / Cedex: 81100 Town: Caserta

Phone:▇▇▇▇▇▇▇▇▇▇▇▇▇ Phone 2:

Education / training
Educational institution and location	Degree	Field of study	From year	To year
Psychology Faculty - Second University of Naples - Italy	Master's Degree / Laurea Magistrale	Psychology	2000	2006
Faculty of Medicine- Second University of Naples - Italy	PhD	Behavioral Sciences and Learning Processes	2007	2009
▇▇▇▇▇▇▇ Institute - Graduate School in Cognitive and Behavioral Psychotherapy - Italy	Specialization / Specializzazione	Cognitive and Behavioral Psychotherapy	2007	2013

Personal Statement:

Our proposal aims to implement a technology-based national surveillance network for the identification of early risk factors for ASD/NDDs in at-risk populations and prevention strategies in the National Health Service. Dr. ▇▇▇▇▇▇▇ is a Clinical Psychologist and PhD in Behavioral Sciences and Learning Processes. Subsequently, she acquired the Specialization in Cognitive Behavioral Psychotherapy at the ▇▇▇▇▇▇▇ Institute in Rome. In the past years, she acquired specific experience in the field of psychodiagnosis and treatment of developmental psychiatric disorders. In the present project, Dr ▇▇▇▇▇▇▇ will be recruited ex-novo for the clinical assessment and diagnosis of NDDs.

Positions and honors

Positions
Institution	Division / Research group	Location	Position	From year	To year
Villa delle Ginestre, Neurorehabilitation Center	Neurorehabilitation	Naples	Consultant (Psychologist)	2022	2023
AOU - ▇▇▇▇▇▇▇▇ II University Hospital	DAI Maternal Infantile	Naples, Italy	Clinical consultant	2016	2018
AOU - ▇▇▇▇▇▇▇▇ II University Hospital	DAI Maternal Infantile	Naples, Italy	Psychologist	2019	2021

Other awards and honors

None

Grant
Funded by Institution	Researcher inst. where ▇▇▇▇▇ is/was performed	Year	Title	Position in Projects	Fund (euro)	Source website grant listed
None	None	0	None	Coordinator	0,00	None

2.11 Additional Research Collaborators n. 4 - Under 40 to hire

Last Name: ▇▇▇▇▇▇

First Name: ▇▇▇▇▇▇▇▇▇

Last name at birth:

Gender: M

Title: Infants recruitment and assessment, EEG and data-entry

Nationality: Italiana

Date of birth: 23/01/1991

Official H index (Scopus or Web of Science): 0.0

Country of residence: ITALY Country of Birth: ITALY Place of Birth: Vico Equense

Scopus Author Id:7005433657 ORCID ID:0000-0002-9764-3058 RESEARCH ID:AIA-8205-2022

Contact address

Current organisation name: Azienda Ospedaliera Universitaria ▇▇▇▇▇▇▇▇ ▇▇, Regione Campania

Current Department / Faculty / Institute / Laboratory name: ▇▇▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ - ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇▇

▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇

▇▇▇▇▇▇: ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇

Postcode / Cedex: 80131 Town: Napoli

Phone:▇▇▇▇▇▇▇▇▇▇▇▇▇ Phone 2:

Education / training
Educational institution and location	Degree	Field of study	From year	To year
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇ of Naples, Italy	Specialization / Specializzazione	Child Psychiatry	2017	2021
School of Medicine, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇ of Naples, Italy	Master's Degree / Laurea Magistrale	Medicine	2009	2017

Personal Statement:

The main goal of the project will be the implementation of a technology-based national surveillance network for the identification of early risk factors for ASD/NDDs in at-risk populations and prevention strategies in the National Health Service. During his residency in child neuropsychiatry, Dr. ▇▇▇▇▇▇ gained extensive experience in the diagnosis and treatment of neurodevelopmental disorders and epilepsy. He has evaluated hundreds of patients with autism and epilepsy focusing on finding possible risk factors for the development of both disorders. His role in the project will be to search for a possible shared electroencephalographic pathway among patients with autism spectrum disorder and epilepsy, starting with screening at-risk infants through EEG monitoring.

Positions and honors

Positions
Institution	Division / Research group	Location	Position	From year	To year
Casa di cura Santa ▇▇▇▇▇ del pozzo	Neurorehabilitation Center	Somma vesuviana, NA	Clinical Consultant (Child Psychiatrist)	2022	2023
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇	Department of Child Neuropsychiatry	Naples, Italy	Resident (Specialization on Child Psychiatry)	2017	2021

Other awards and honors

None

Grant
Funded by Institution	Researcher inst. where ▇▇▇▇▇ is/was performed	Year	Title	Position in Projects	Fund (euro)	Source website grant listed
None	None	0	None	Collaborator	0,00	None

2.17 Expertise Research Collaborators

Selected peer-reviewed publications of the Research Group / Collaborators
Collaborato	Title	Type	Pag	Vol	Year	DOI	PMID	Cit.**	P.*
▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇	▇▇▇▇ neurological phenotype in a family carrying a novel N- terminal null GRIN2A variant	Article	NOT_FO UND	65	2022	10.1016/j.ejmg.2022.104 500	35367634	0	O
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	Guidelines for the use and interpretation of assays for monitoring autophagy (4th edition)	Guideline	1-382	17	2021	10.1080/15548627.2020. 1797280	33634751	149	O
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	▇▇▇▇▇▇▇▇▇▇▇▇ inhibits melanoma in vitro and in vivo	Article	▇▇▇	▇▇	▇▇▇▇	10.1186/s13046-020- 01719-3	33028392	8	O
Mosca ▇▇▇▇▇	▇▇▇▇▇▇▇▇▇▇▇▇▇ and coronavirus disease-2019: Ad interim indications of the Italian Society of Neonatology endorsed by the Union of European Neonatal & Perinatal Societies	Article	1-8	16	2020	10.1111/mcn.13010	32243068	122	L
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇	Clinical Characteristics of Hospitalized Individuals Dying with COVID-19 by Age Group in Italy	Article	1796- 1800	75	2020	10.1093/gerona/glaa146	32506122	90	O
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇	COVID-19 Disease Severity Risk Factors for Pediatric Patients in Italy	Article	1-4	146	2020	10.1542/peds.2020- 009399	32665373	73	L
▇▇▇▇▇▇▇ ▇▇▇▇▇▇	Cognitive Function in Children With Idiopathic Subclinical Hypothyroidism: Effects of 2 Years of Levothyroxine Therapy	Article	e774- e781	105	2020	10.1210/clinem/dgaa046	32002552	4	O
▇▇▇▇ ▇▇▇▇▇▇▇▇▇	▇▇▇▇▇▇▇ left-lateralized pattern of event-related EEG oscillations in infants at familial risk for language and learning impairment	Article	1-17	22	2019	10.1016/j.nicl.2019.1017 78	30901712	15	O
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	▇▇▇▇▇▇▇▇▇▇ role of phytochemicals on oxidative stress and age-related diseases	Review	1-17	2019	2019	10.1155/2019/8748253	31080832	143	O
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	▇▇▇ microbiota features in young children with autism spectrum disorders	Article	1-12	9	2018	10.3389/fmicb.2018.031 46	30619212	89	O
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇	From early stress to 12-month development in very preterm infants: Preliminary findings on epigenetic mechanisms and brain growth	Article	1-15	13	2018	10.1371/journal.pone.01 90602	29304146	27	F

Collaborato	Title	Type	Pag	Vol	Year	DOI	PMID	Cit.**	P.*
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇	The impact of immunization programs on 10 vaccine preventable diseases in Italy: 1900-2015	Article	1435- 1443	36	2018	10.1016/j.vaccine.2018.0 1.065	29428176	43	F
▇▇▇▇ ▇▇▇▇▇▇▇▇▇	Distinct ERP profiles for auditory processing in infants at-risk for autism and language impairment	Article	1-11	8	2018	10.1038/s41598-017- 19009-y	29335488	14	F
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	TNF-alpha and metalloproteases as key players in melanoma cells aggressiveness	Article	326-339	37	2018	10.1186/s13046-018- 0982-1	30591049	38	O
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▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	Intestinal Dysbiosis and Yeast Isolation in Stool of Subjects with Autism Spectrum Disorders	Article	349-363	182	2017	10.1007/s11046-016- 0068-6	27655151	67	L
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇	Detection of a chikungunya outbreak in central Italy, August to September 2017	Article	11-14	22	2017	10.2807/1560- 7917.ES.2017.22.39.17-	29019306	92	O
▇▇▇▇▇▇ ▇▇▇▇▇▇	Conduct disorders and psychopathy in children and adolescents: Aetiology, clinical presentation and treatment strategies of callous- unemotional traits	Review	1-11	43	2017	10.1186/s13052-017- 0404-6	28931400	23	F
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇	▇▇▇▇▇▇▇▇▇ Transporter Gene (SLC6A4) Methylation Associates With Neonatal Intensive Care Unit Stay and 3-Month-Old Temperament in Preterm Infants	Article	38-48	87	2016	10.1111/cdev.12492	26822441	35	O
▇▇▇▇ ▇▇▇▇▇▇▇▇▇	Auditory discrimination predicts linguistic outcome in Italian infants with and without familial risk for language learning impairment	Article	23-34	20	2016	10.1016/j.dcn.2016.03.0 02	27295127	14	O
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▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇	▇▇▇▇▇▇▇▇▇ outcome after maternal cancer diagnosed during pregnancy	Article	1824- 1834	373	2015	10.1056/NEJMoa150891 3	26415085	116	O

Collaborato	Title	Type	Pag	Vol	Year	DOI	PMID	Cit.**	P.*
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇	▇▇▇▇▇▇▇▇ near infrared spectroscopy oximetry in extremely preterm infants: Phase II randomised clinical trial	Article	1-11	350	2015	10.1136/bmj.g7635	25569128	118	O
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇	Pain-related stress during the neonatal intensive care unit stay and SLC6A4 methylation in very preterm infants	Article	1-9	9	2015	10.3389/fnbeh.2015.000 99	25941480	29	O
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	Use of Machine Learning to Identify Children with Autism and Their Motor Abnormalities	Article	2146- 2156	45	2015	10.1007/s10803-015- 2379-8	25652603	89	O
Mosca ▇▇▇▇▇	Sustained lung inflation at birth for preterm infants: A randomized clinical trial	Article	e457- e464	135	2015	10.1542/peds.2014-1692	25624390	99	O
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇	Antimicrobial resistance: A global multifaceted phenomenon	Article	309-318	109	2015	10.1179/2047773215Y.0 000000030	26343252	▇▇▇	▇
▇▇▇▇ ▇▇▇▇▇▇▇▇▇	▇▇▇▇▇▇▇▇ and ROBO1: Evidence on association with reading and pleiotropic effects on language and mathematics abilities in developmental dyslexia	Article	189-197	59	2014	10.1038/jhg.2013.141	24430574	34	O
▇▇▇▇▇▇ ▇▇▇▇▇▇	Child behaviour checklist emotional dysregulation profiles in youth with disruptive behaviour disorders: Clinical correlates and treatment implications	Article	191-196	225	2015	10.1016/j.psychres.2014 .11.019	25480545	32	O
▇▇▇▇▇▇ ▇▇▇▇▇▇	Child behavior checklist dysregulation profile in children with disruptive behavior disorders: A longitudinal study	Article	249-253	186	2015	10.1016/j.jad.2015.05.06 9	26254616	23	O
▇▇▇▇ ▇▇▇▇▇▇▇▇▇	▇▇▇▇▇▇ mediates susceptibility to intelligence quotient and cognitive impairments in developmental dyslexia	Article	9-20	25	2015	10.1097/YPG.00000000 00000068	25426763	18	O
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	Spatial and temporal attention in developmental dyslexia	Article	1-13	8	2014	10.3389/fnhum.2014.003 31	24904371	51	O
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	Magnocellular-dorsal pathway and sub-lexical route in developmental dyslexia	Article	1-11	8	2014	10.3389/fnhum.2014.004 60	25009484	51	O
▇▇▇▇▇▇ ▇▇▇▇▇▇	Epidemiological study on behavioural and emotional problems in developmental age: Prevalence in a sample of Italian children, based on parent and teacher reports	Article	1-7	40	2014	10.1186/1824-7288-40- 19	24533835	15	O

Collaborato	Title	Type	Pag	Vol	Year	DOI	PMID	Cit.**	P.*
Mosca ▇▇▇▇▇	▇▇▇▇▇▇ lactoferrin supplementation for prevention of necrotizing enterocolitis in very-low-birth-weight neonates: A randomized clinical trial	Article	S60-S65	90	2014	10.1016/S0378- 3782(14)70020-9	24709463	112	O
▇▇▇▇▇ ▇▇▇▇▇	The pathophysiology of retinopathy of prematurity: An update of previous and recent knowledge	Review	2-20	92	2014	10.1111/aos.12049	23617889	104	L
▇▇▇▇▇▇▇ ▇▇▇▇▇▇	Analysis of RBFOX1 gene expression in lymphoblastoid cell lines of Italian discordant autism spectrum disorders sib- pairs	Article	242-245	28	2014	10.1016/j.mcp.2014.05.0 01	24938762	3	O
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	Antibodies against food antigens in patients with autistic spectrum disorders	Article	1-12	2013	2013	10.1155/2013/729349	23984403	35	L
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇ of autism spectrum disorders: Fitting the pieces of the puzzle together	Article	26-35	81	2013	10.1016/j.mehy.2013.04. 002	23622947	27	L
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	Action video games make dyslexic children read better	Article	462-466	23	2013	10.1016/j.cub.2013.01.0 44	23453956	262	O
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇	Eye-hand coordination in children with high functioning autism and ▇▇▇▇▇▇▇▇'▇ disorder using a gap-overlap paradigm	Article	841-850	43	2013	10.1007/s10803-012- 1623-8	22865152	27	L
Mosca ▇▇▇▇▇	▇▇▇▇▇-term, long-term and paracrine effect of human umbilical cord-derived stem cells in lung injury prevention and repair in experimental bronchopulmonary dysplasia	Article	475-484	68	2013	10.1136/thoraxjnl-2012- 202323	23212278	149	O
▇▇▇▇▇▇▇ ▇▇▇▇▇▇	The association of rs4307059 and rs35678 markers with autism spectrum disorders is replicated in Italian families	Article	177-181	22	2012	10.1097/YPG.0b013e32 835185c9	22739633	22	O

* Position: F=First L=Last C=Correspondent O=Other N=Not applicable

** Autocertificated

3 - Ethics

1. HUMAN EMBRYOS/FOETUSES
Does your research involve Human Embryonic Stem Cells (hESCs)?	No
Does your research involve the use of human embryos?	No
Does your research involve the use of human foetal tissues / cells?	No

2. HUMANS
Does your research involve human participants?	Yes
Does your research involve physical interventions on the study participants?	No
3. HUMAN CELLS / TISSUES
Does your research involve human cells or tissues (other than from Human Embryos/ Foetuses?	Yes
4. PERSONAL DATA
Does your research involve personal data collection and/or processing?	Yes
Does your research involve further processing of previously collected personal data (secondary use)?	No
5. ANIMALS
Does your research involve animals?	No
6. ENVIRONMENT & HEALTH and SAFETY
Does your research involve the use of elements that may cause harm to the environment, to animals or plants?	No
Does your research deal with endangered fauna and/or flora and/or protected areas?	No
Does your research involve the use of elements that may cause harm to humans, including research staff?	No
7. DUAL USE
Does your research involve dual-use items in the sense of Regulation 428/2009, or other items for which an	No
8. EXCLUSIVE FOCUS ON CIVIL APPLICATIONS
Could your research raise concerns regarding the exclusive focus on civil applications?	No
9. MISUSE
Does your research have the potential for misuse of research results?	No
10. OTHER ETHICS ISSUES
Are there any other ethics issues that should be taken into consideration? Please specify	No

X

I confirm that I have taken into account all ethics issues described above and that, if any ethics issues apply, I will complete the ethics self-assessment and attach the required documents.

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Eligibility
I acknowledge that I am aware of the eligibility requirements for applying as specified in the Call- PNRRXXXX_M6/C2, and certify that, to the best of my knowledge my application is in compliance with all these requirements. I understand that my proposal may be declared ineligible at any point during the evaluation or granting process if it is found not to be compliant with these eligibility criteria.	X
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For communication purposes only, the MoH asks for your permission to publish,in whatever form and medium, your name, the proposal title, the proposal acronym, the panel, and host institution, should your proposal be retained for funding.	X
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5 – Description Project

Summary description

ASD and other NDDs are chronic and impactful disorders frequently found in the general population (i.e. ASD: 1 every 77 children; intellectual disability: 1 every 50). ASD, often in comorbidity with other NDDs, is diagnosed after 3-4 years of age despite the presence of impairment in a range of skills in the first year of life. Understanding how ASD unfolds from birth onwards is critical to promote early screening and implement early interventions, which limit the impact of core and associated symptoms and improve developmental outcomes in a significant proportion of children.

BABY@NET will address this very important issue by monitoring three at-risk populations (siblings of children with ▇▇▇,

infants born preterm, and/or SGA) during early postnatal period through a clinical/experimental protocol including a set of behavioral, neurophysiological and biological parameters found to be impaired in ASD/NDDs children. This approach will improve early detection of ASD and other NDDs.

Background / State of the art

The global prevalence of ASD has shown a marked increase in the last decades, with a median prevalence of 65/10,000 (▇▇▇▇▇▇ et al., 2022). In Italy, a recent study of the National ASD Observatory estimated a prevalence rate of 1 every 77 children in the age range 7-9 (2019). Baby siblings of ASD children, ▇▇▇▇▇ for Gestational Age (SGA, weight below the 3rd percentile) and premature infants (born between 26 and 31 gestational weeks) are three populations sharing higher risk of ASD and NDDs than the general population. The NIDA Network, the largest multi-center and multi-disciplinary Network in Italy, aimed to guide surveillance programs for the early diagnosis and intervention of ASD and to improve the quality of life of children with ASD and their families (▇▇▇▇▇▇ et al. 2021). Moreover, NIDA research activities focused on the identification of behavioral/biological markers for early detection of ASD (▇▇▇▇ et al. 2021; ▇▇ ▇▇▇▇▇▇▇ et al. 2021). Delays or unusual patterns in several developmental domains (motor, language, social, visual processing) are early warnings of NDDs in the first three years of life (▇▇▇▇▇ et al. 2020). Promising biomarkers (i.e. genetic, epigenetic, immune) have been developed and their role in the diagnosis of NDDs need to be validated (Dall'Aglio et al. 2018; ▇▇▇▇ et al. 2019). This proposal aims to empower experimental and clinical protocols using sophisticated and non-invasive technologies that can be applied to at-risk populations.

Description and distribution of activities of each operating unit

The BABY@NET project requires a multidisciplinary approach satisfied by the partners¿ backgrounds, scientific experiences and expertise. We believe that the co-partnership of these professionals will make the success probability of the present proposal very high.

UO1 will take care of the Ethics Committee approval and coordinate the entire project making sure everyone adheres to the established protocol. In particular, the following activities will be performed by the four operating units:

1- Recruitment of at-risk populations: UO1, UO2, UO3, UO4

2- Clinical surveillance of at-risk populations (at five time-points from 6 to 36 months) through the national NIDA protocol and newly store-and-forward telehealth measures: UO1, UO2, UO3, UO4

3- Experimental tasks in the first 12 months of age using cutting-edge techniques to detect early risk markers of ASD and other NDDs (motor assessment, infant crying, sensory processing and social communication development using EEG): UO1, UO3, UO4

4- Telehealth support activities for health professionals of NICUs and CPUs: UO1, UO2, UO3, UO4

5- Biological samples collection for piloting genetic/epigenetic, metabolomic and secretome analyses in NICUs: UO2, UO4 6- Biological analyses:

Genetic and epigenetic - UO2 in collaboration with the laboratory of Genome Biology Unit, INGM, Milan and UO3 in collaboration with the Laboratory of Molecular biology at IRCCS Medea;

Metabolomic - UO4 in collaboration with the ImmunoNutritionLab at the Maternal and Child Health Dept.;

Secretome (inflammatory mediators analysis) - UO1 with the support of the ISS Core Facilities Technical-Scientific Service (▇▇▇▇▇://▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇.▇▇/▇▇/▇▇▇▇.▇▇▇?▇▇▇▇▇:▇▇▇▇▇);

7- Improvement of web-based NIDA platform for data-entry of clinical, telehealth, and experimental data: UO1 8- Statistical Analyses: UO1 (CO-PI)

9- Dissemination of the results and scientific publications: UO1, UO2, UO3, UO4

5.4 Specific Aims and Experimental Design

Specific aim 1

Aim 1: To establish a standardized surveillance network for developing age-specific clinical/experimental protocols able to

early identify infant/children at risk for ASD and other NDDs

The NIDA Network has provided a well-established clinical protocol for the surveillance of 6 to 36 months infants at-risk for ASD/NDDs in all Italian regions. With the current BABY@NET project, we intend: 1. to expand the NIDA protocol to the whole national territory; 2. to extend the research field by collecting behavioral, neurophysiological and biological material to further investigate and get new insights into the pathogenetic features and early clinical presentation of ASD and other NDDs in order to identify early specific biomarkers to be included in clinical surveillance programs. In detail, we intend to investigate at specific time points in the first 12 months of at-risk infants` life, vocal, motor and social performances, EEG activity, genetic/epigenetic, metabolomic and secretome profiles, that have been found altered in ASD/NDDs children.

These purposes are based on promising experimental data collected since 2010 in our previous pilot studies (▇▇▇▇▇▇▇▇▇▇ et al. 2020, ▇▇▇▇▇▇ et al. 2020, Chericoni et al. 2021, ▇▇ ▇▇▇▇▇▇▇ et al. 2016, 2021, ▇▇▇▇▇▇▇▇▇ et al. 2020, Marchi et al. 2019, Purpura et al. 2017, ▇▇▇▇ et al. 2018) showing that early motor, language, and social attentional trajectories of high-risk infants for ASD, who later received a diagnosis of NDDs, appeared different compared to typically developing infants. By applying novel automatic and semiautomatic technological tools, the NIDA research activities identified potential early behavioral precursors of altered development linked to the NDD diagnosis (▇▇▇▇▇▇▇▇▇▇ et al. 2020, ▇▇▇▇▇▇ et al. 2020, Marchi et al. 2019). See figure with preliminary data attached.

Emerging evidence suggests that epigenetic processes may help promote inflammatory processes that influence the risk of chronic disease, including NDDs. Moreover, metabolic imbalances are strictly linked to inflammation. Therefore, elucidation of the specific epigenetic and metabolic pathways involved in the modulation of inflammation is of great interest in seeking a clear mechanistic understanding of the pathogenesis of ASD (▇▇▇▇ et al. 2015; ▇▇▇▇▇▇▇ et al. 2020). A specific pilot study will be performed on preterms and SGA infants, by cord blood and meconium sampling at U02 and UO4, with the aim of identifying epigenetic, metabolomic, and secretome (inflammatory-related) markers linking early life exposures to neurodevelopmental outcome (▇▇▇▇▇▇▇ et al. 2021).

Specific aim 2

Aim 2: To provide telehealth support to professionals working in NICUs and CPUs to enhance monitoring of at-risk infants and speed up diagnostic and intervention processes with the ultimate goal of improving the quality of life of children with ASD/NDDs and their families.

The shortage of personnel and expertise for the collection and analysis of experimental data and specific tests for monitoring at-risk infants in NICUs follow-up and CPUs in the Italian territory leads to the urgent establishment of a multidisciplinary telehealth team. It will promote and support health professionals in the neurodevelopmental and behavioral assessments of at-risk populations by audio and video analyses and test scoring. The telehealth support will be provided through the IT platform specifically implemented in the BABY@NET project on the National ASD Observatory website (▇▇▇▇▇://▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇.▇▇/▇▇▇▇-▇▇-▇▇▇▇▇▇▇▇▇▇▇▇▇-▇▇▇-▇▇▇▇▇▇▇▇-▇▇-▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇).

Specific aim 3

Aim 3: To detect ASD/NDDs risk factors for planning prediction and prevention strategies

Early vocal, motor, sensory processing and social communication parameters collected and analyzed in the first 12 months of infants' life, along with clinical/behavioral/biological variables collected by CPUs and NICUs from 6 to 36 months of age will be entered into the IT platform specifically implemented in the present BABY@NET project.

UO1 Co-PI, leading the Epidemiology, Mathematical Models and Biostatistics unit of the ISS, will implement high- performance computing and artificial intelligence to the multidimensional clinical and biological datasets collected in the digital platform with the aim of identifying predictive risk factors associated with the ASD/NDDs diagnoses. The identification of risk factors will be used for planning and promotion of prediction and prevention strategies during the Well-Child Care Visits, as well as to further specialize the training of professionals in graduate schools of child neuropsychiatry,

neonatology, and pediatrics.

Experimental design aim 1

Infant behavioral, neurophysiological and clinical indexes will be monitored using a longitudinal multi-observational protocol specifically designed to be implemented as part of routine assessment visits at CPUs/NICUs.

Considering differences in the prevalence of ASD/NDDs in those three at-risk populations, an estimated sample of n=62 siblings of ASD children, 86 SGA, 86 preterm and a comparable sample of low-risk (LR) infants (at term and appropriate for gestational age) will be recruited between birth and 12 months of age through the CPUs/NICUs of the UOs involved in the project and the NIDA Network. Up to now, the NIDA Network has already recruited and monitored 664 siblings of ASD children, 459 preterm, 153 SGA, and 158 LR infants from birth to 36 months through a clinical/experimental protocol. Given the limited time available in the present project for the enrollment and evaluation, we will collect specific behavioral/experimental data in the first 12 months of age that have been found promising ASD/NDD risk predictors. These data will be pooled together with data previously collected through the NIDA Network to enhance the positive predictive value of behavioral/clinical variables previously found associated with ASD/NDD risk.

Recruitment procedure: parents will be requested to sign a written informed consent based on an exhaustive, informative paper encompassing the scientific rationale and a precise timeline of appointments.

Inclusion criteria

- LR infants: born after 37 GW and with birth weight >= 2500 g;

- High-risk (HR) infants: siblings of children already diagnosed with ASD; SGA: birth weight below the 3rd percentile; Preterm: born between 26+0 and 31+6 GW;

- Apgar index over 7 at 5th minute.

Exclusion criteria

- Infants born before 26 GW;

- Presence of major acquired perinatal brain lesions, severe cardiovascular, organ and system diseases, known genetic syndromes related to ASD, and medical conditions affecting brain development or infant's ability to participate in the study

Infants will be subjected to a multi-observational protocol up to 36 months (mo) of age (see Methodology section). Preterm and/or SGA infants will be tested at the corrected postmenstrual age. The clinical and experimental protocol includes:

1. Study-specific and structured parent interview collected at the time of recruitment regarding gestational and family history, childbirth, socio-demographic variables, and environmental factors.

2. Experimental data collection at birth, 3, 6, and 12 mo: a. auxological and head circumference measurements; b. developmental trajectories of spontaneous and intentional motor movements, vocal/language/communication performances; c. early audio-visual sensory processing and social skills measured by an innovative integrated electrophysiological + eye tracking approach at 12 mo.

3. Clinical/diagnostic assessment for investigating longitudinal cognitive, motor, language, and adaptive profiles and determining the presence/absence of ASD/NDD diagnosis using standardized tools/tests and structured parental interviews at 6, 12, 18, 24 and 36 mo.

Infants identified at risk or with a provisional/stable diagnosis will be immediately included in early individualized intervention programs.

A specific pilot study will be performed on a subsample of 30 LR and 30 preterm infants born in UO2/UO4 neonatology Units. Cord blood and meconium will be collected at birth to identify genetic/environmental/inflammatory-related markers linking early life exposures to the neurodevelopmental outcome.

Primary Outcome measure:

- Stability and accuracy of the predictive value of each risk index identified at birth, 3-6-12 mo through the correlation with the diagnostic outcome and ASD/NDDs-related traits at 18, 24 and 36 mo.

Secondary Outcome Measures:

- Genetic/environmental/inflammatory-related markers linking early life exposures to the neurodevelopmental outcome.

Experimental design aim 2

During the first three months of the BABY@NET project, an integrated online environment (platform) dedicated to the health professionals working at the CPUs and NICUs will be developed. The platform will provide a wide set of services (audio and video-uploading, analysis of motor, vocal and social features, data-entry and automated test scoring, file sharing, one to one live chats) supporting professionals during the longitudinal behavioral and clinical assessment in an efficient, effective, and trustworthy way, at low cost and with high clinical value.

The UO1 will establish and coordinate the BABY@NET multidisciplinary telehealth team, involving child neuropsychiatrists, psychologists, speech- and motor-therapists, neonatologists and researchers working within the UOs involved in the project, dedicated personnel (second collaborators) and under-40 researchers hired ex-novo through the present proposal. The telehealth team will first be trained by the principal collaborators and then provisioned to all professionals working in the CPUs/NICUs of the NHS. This will be possible thanks to the BABY@NET digital platform that will provide clinical care, test scoring/audio-video analyses and online support.

Throughout the entire duration of the BABY@NET surveillance, each CPU/NICU will have a specific web space on the IT platform. Within each CPU/NICU, the digital system will assign a personal alphanumeric code to each infant, and it will be possible to upload all audio-video recordings data (vocal, socio-communicative, motor), structured interviews/gold standard tests, cognitive assessment and raw data of the neurophysiological/biological variables included in the experimental protocol. The multidisciplinary telehealth team will provide spectrographic analysis of the infant's crying, analysis of spontaneous and intentional motor skills, consonant inventory, canonical syllables, nonvocal vocalizations, and perform test scoring.

In the event of a recurrence of the COVID-19 outbreak and the discontinuation of face-to-face assessments, we will make available to all national NICUs/CPUs connected to the digital platform a new store-and-forward telehealth method, namely teleNIDA, designed to detect atypical behaviors in infants/infants reported for ASD-related concerns. The teleNIDA was developed for toddlers aged from 18 to 30 months of age and provides home-setting observation of potential atypical behaviors associated with ASD, guiding parents to capture four 5-minute videos of their child during specific activities: free- play, play with parent, mealtime and book sharing. The teleNIDA scores have been compared to ADOS concern categories in a sample of 51 at-risk toddlers and the results showed high specificity (70%) and sensitivity (83%). Notably, our results related to interrater reliability indicated 89 to 96% accuracy among 14 raters from 7 different pediatric clinical centers in five Italian regions. This strong agreement among experienced ASD raters will ensure the feasibility, repeatability and reproducibility of teleNIDA throughout the Italian territory.

Altogether, the telehealth support system will increase the accuracy of clinical/experimental data collection of infants within the BABY@NET team, speeding up the diagnostic process of infants to detect early developmental atypicalities and intervention programs.

Secondary Outcome measures:

- Increase of at least 25% in the number of CPUs/NICUs in the NIDA Network performing the clinical/experimental surveillance protocol;

- Increase of at least 25% in the number of HR infants enrolled/monitored compared with the current NIDA surveillance protocol.

Experimental design aim 3

Infants' data, collected through the standardized surveillance network protocol (AIM 1) and online expert support provided by the telehealth team (AIM 2), will be merged with data collected since 2010 by the NIDA Network (including 158 LR infants, 664 ASD siblings, 459 preterm and 153 SGA infants) and used to track vocal, motor, and social developmental trajectories in each population. Thanks to the BABY@NET project, we will further outline the infants' developmental profile, including behavioral, neurophysiological and biological parameters.

In addition, a predictive model will be implemented to forecast the ASD/NDD risk based on the clinical, experimental (vocal, motor, sensory and social measures) and genetic/epigenetic, metabolomic and secretome parameters collected. Both classic statistical approaches and machine learning algorithms will be applied.

In our previous Ministry of Health Network project (completed in February 2021), a predictive model was developed on a sample of 227 children with HR of ASD, including 34 with ASD diagnosis, 57 with NDD and 136 without diagnosis or ASD/NDD related traits. Through the analysis of the scores assigned to children on clinical tests and at specific time points (6-12-18 months), our predictive model was able to correctly classify, at 12 months, the 34% of subjects with ASD and 93% of subjects without a diagnosis, and, at 18 months, the 80% of subjects with ASD and 96% of subjects without a diagnosis. These results highlight the high predictive value of our model for the diagnosis of ASD and NDD long before 24-36 months of age.

In the present project, we will build a new predictive model adding (to the previously implemented NIDA clinical protocol) other experimental tasks/variables found to be predictive of ASD/NDD risk in HR infants populations (AIM 1). Adding those scores to our algorithm, we may enhance its positive predictive value in terms of accuracy (sensitivity and specificity).

The BABY@NET project, through the testing and validation of this predictive model, will allow the automatic and early identification of infants with scores indicative of ASD/NDD risk. In this way, infants will have the unique opportunity to access early, individualized, and intensive interventions.

UO1 coordinates the National Neurodevelopmental disorder group that, in the past years, defined and implemented the developmental surveillance in the 0- to 3-year-old routinary well-child care visits and the associated promotion of psychoeducational strategies to intervene on the detected behavioral atypicalities. Predictive ASD/NDD risk factors identified by BABY@NET will be used to update the existing developmental surveillance and promote evidence-based training activities on early 'red flags' for pediatricians, neonatologists and kindergarten teachers. The multidisciplinary team involved in the present project will also develop evidence-based practices and/or guidelines for the early detection of ASD/NDDs in NICU-follow-up services. In addition, UO1's extensive experience and commitment to the training of NHS health workers will be used to promote specialized training courses for health workers in the Italian territory in collaboration with the Italian Society of Neonatology and the Italian Society of Child and Adolescent Neuropsychiatry.

Primary outcome measure:

- Build a new predictive model and evaluate its accuracy in terms of positive predictive value of ASD/NDD risk.

Secondary outcome measures:

- Update the developmental surveillance implemented by the NIDA Network within the well-child care visits between 0-36 months of infants age;

- Develop evidence-based practices and/or guidelines for the early detection of ASD/NDDs in the NICU-follow-up services;

- Training programs for kindergarten teachers and professionals in graduate schools of child neuropsychiatry, neonatology, and pediatrics.

Picture to support preliminary data

PNRR figure def.pdf

Hypothesis and significance

ASD is a heterogeneous group of neurodevelopmental disorders with complex multifactorial etiologies and characterized by socio-communicative difficulties associated with the presence of restricted and repetitive behaviors, activities and interests. According to the UO1's study, ASD affects 1 child in 77 and at least 500,000 households in Italy. Because disability at the societal level persists throughout life and requires complex interventions, ASD entails a very high cost to the NHS and burden on families. The estimated average cost of caring for a person with ASD throughout life is approximately 1.5 million euros (▇▇▇▇▇▇▇▇ et al. 2014).

Although ASD is present from the earliest months of life, diagnosis can only be reliably made from 24 months of age. The gold-standard diagnostic tests for ASD are based on the detection of behavioral symptoms most evident from 24-30 months. Studying what happens in the first 12 months of age is of great interest because early detection of the risk of ASD, even before the disorder fully expresses itself, and prompt intervention can reduce its interference with development and mitigate its clinical outcomes. Identification of ASD risk factors is crucial since early and individualized treatments are able to limit the impact of symptomatology and the child/adolescent/adult's social, educational and work inclusion in the community.

Recently, in view of the genetic origin of ASD, research on predictive factors has been directed toward studying the early developmental stages of younger siblings of children already diagnosed with ASD. Indeed, the sibling population has a 10- fold higher risk than the general population of developing ASD. Moreover, infants of preterm birth (born between 26 and 31 gestational weeks) and SGA (weight below the 3rd percentile) are considered at heightened risk for ASD/NDDs.

At present, premature and SGA infants are surveilled through heterogeneous protocols investigating only behavioral, neurological, and general growth endpoints. Thus, the establishment of a standardized multi-observational protocol including a set of behavioral, neurophysiologic and molecular indexes, would improve the detection of early signs of ASD/NDDs. This protocol will be non-invasive and easy-to-perform in order to allow its implementation in nurseries, intensive- and primary-care settings of the entire national territory.

Our preliminary data, consistent with existing scientific evidence, indicate the potentiality to identify early motor, vocal, and social markers that are effective in predicting abnormal outcomes in infants at risk for NDDs. A multi-observational protocol applicable from birth to 36 months and containing non-invasive and easy-to-perform tools in the NICUs and CPUs, such as analysis of vocal, motor and social domains, concomitantly with neurophysiological and biological parameters, will significantly support the early detection of those infants at risk for developmental difficulties.

The present study is highly innovative and the results are expected to be useful for both clinicians and researchers. On the one hand, the study will provide health professionals with a model to promote early screening methods and implement early interventions, which have been shown to limit the impact of autistic symptomatology and improve the quality of life of autistic individuals and their families. On the other hand, by using innovative experimental techniques in the first year of life, researchers in pediatric and developmental sciences will be able to adopt new and reliable measures and parameters to study (a)typical processes during the first year of life. The BABY@NET research project promotes innovative integration of advanced neuroscientific approaches to clinically at-risk populations.

5.5 Methodologies and statistical analyses

Methods of data collection

Experimental/clinical data will be collected, monitored, and audited monthly in the dedicated and secure BABY@NET digital-platform.

Recruitment: informed consent form, anamnestic and socio-demographic data (including gestational, family history, and environmental factor data) collected by parents' interview.

Experimental/clinical data collection and methods.

1) Experimental data collection at birth, 3, 6, and 12 mo:

a. auxological data collection and head circumference measurement as in Crucitti et al. 2020;

b. video recordings by Intel Realsense Depth Camera D435 and wireless accelerometers for spontaneous and intentional motor movements analysis by General Movements assessment scales and kinematic analysis through MOVIDEA software as in Baccinelli et al. 2020 and ▇▇▇▇▇▇ et al. 2020;

c. audio recordings by TASCAM Zoom H1n for infant crying spectrographic analysis and melody as in ▇▇▇▇▇ et al. 2017; vocalization samples collected during play with mother and a standard set of toys for analysis of consonant inventory, presence of canonical syllables, non-speech vocalizations at 12 mo as in ▇▇▇▇ et al. 2011;

d. at 12 mo, integrated EEG-eye tracker experimental task whereby social (speaking faces; ▇▇▇▇ et al., 2022) and non- social videos (moving toys) will be presented (first condition: audio-visual synchrony; second condition: audio-visual asynchrony). Data will be analyzed in Matlab, using available programs (e.g., EEGLAB/ERPLAB, EEG-EYE) and homemade scripts.

2) Clinical data collection at 6, 12, 18, 24, and 36 mo. Neurodevelopmental profiles of infants/toddlers will be evaluated in the CPUs/NICUs involved in the present proposal and in the NIDA Network using the following methods:

a. Cognitive, language, adaptive, and socio-communicative development evaluated by standardized tools/structured interviews with parents: ▇▇▇▇▇▇▇▇▇ Mental Developmental Scales (6, 12, 18, 24, 36 mo), ADOS-2 (18, 24, 36 mo), Vineland-II (12, 18, 24, 36 mo), MacArthur questionnaire (12, 18, 24 mo), Child Behavior CheckList (18, 24, 36 mo), Parent Stress Index (6, 12, 18, 24, 36 mo), M-CHAT (18 mo), Early Motor Questionnaire (12, 18 mo), and First Year Inventory (12 mo).

b. Home observations of social-communicative skills will be carried out only in case of recurrence of COVID-19 outbreak and discontinuation of face-to-face assessments (18 and 24 mo). Parents/carers will be asked to make 5-minute video- recordings of 4 everyday activities (free-play, play with parents, mealtime, and book sharing). Videos will be collected and scored by the telehealth team through the adapted Systematic Observation of Red Flags (Dow et al. 2020).

The telehealth team will support the CPUs/NICUs with the audio-video recordings and analysis of crying/vocal and motor performances, test scoring, and data entry in the BABY@NET web platform.

3) Biological sampling and analyses for the pilot study.

At birth, cord blood samples (200-500 µl) will be collected and subjected to:

a. Measurement of LINE1 promoter methylation. Genomic DNA extraction, LINE1 methylation and bioinformatic analysis as in ▇▇▇▇▇▇▇ et al. 2021.

The first meconium will be collected into a sterile tube and suspended in phosphate-buffered saline at a concentration of 100 g/L. Samples will be filtered and stored at -80°C until use:

b1. Stool metabolomic analysis will be performed as described in ▇▇▇▇▇▇▇ et al. 2020. Two-microlitre of samples will be processed through the gas chromatography-mass spectrometry system.

b2. Secretome analysis: a large number of soluble molecules (cytokines/chemokines, growth factors, and other

inflammation-related molecules) will be measured using xMAP technology on the Luminex platform. Commercial kits (Bio- Rad Laboratories and/or R&D Systems) will be used. Results will be confirmed with ELISA or other immunometric analyses.

Statistic plan

Our preliminary data indicate that a predictive model with three clinical variables (collected through the 6-36 months NIDA protocol) has high predictive value and correctly classifies 34% of subjects with ASD and 93% of subjects without a diagnosis at 12 months and 80% of subjects with ASD and 96% of subjects without a diagnosis at 18 months of age. Based on UOs preliminary results (motor/vocal/sensory/social risk indexes identified by the NIDA Network and illustrated in the Preliminary Results Figure), we estimated the sample size by assuming a prevalence of ASD on these three selected at- risk populations of 15% in ASD siblings and 7% in preterm/SGA infants, and considering 5 variables (adding 2 experimental variables from the actual 0-12 months protocol) to be included in the model. According to such assumptions, 62 siblings of children with ▇▇▇, 86 preterm, 86 SGA and LR infants (at least 62) are needed to be included in this study. This estimated sample size, required for the development of a new multivariable prediction model, has been calculated using the criteria proposed by ▇▇▇▇▇ et al. 2020 by the software STATA 16.1.

Interim analysis

One formal statistical interim analysis is planned to take place when the study will be at least 6 months into recruitment. Aim of the interim analysis will be verifying the number of subjects recruited, biological samples collected and clinical tests performed. Since we estimate to recruit all subjects within the first 12-15 mo of the project, if an appropriate number of infants will not be reached, we will increase the catchment recruitment area through other CPUs/NICUs of the NIDA Network. Another interim analysis will be performed at 12 mo to analyze preliminary experimental/clinical data and elaborate a report for the Ministry of Health.

Final analysis

According to the power analysis, 296 children who complete the follow-up with available data for the primary outcomes will be included in the final analysis. Considering a drop-out rate of 5% (as in the Surveillance NIDA Network in the last 10 years), 311 children will be enrolled to guarantee statistical power for final analysis.

The following outcome measures will be analyzed. Primary outcome measures:

1. Stability and accuracy of the predictive value of each risk index identified at birth, 3-6-12 mo through the correlation

with the diagnostic outcome and ASD/NDDs-related traits at 18, 24 and 36 mo (AIM 1);

2. Build a new predictive model and evaluate its accuracy in terms of positive predictive value of ASD/NDD risk (AIM 3).

Secondary outcome measures:

a. Genetic/environmental/inflammatory-related markers linking early life exposures to the neurodevelopmental outcome (AIM 1);

b. Increase of at least 25% in the number of CPUs/NICUs in the NIDA Network performing the clinical/experimental surveillance protocol (AIM 2);

c. Increase of at least 25% in the number of HR infants enrolled/monitored compared with the current NIDA surveillance protocol (AIM 2);

d. Update the developmental surveillance implemented by the NIDA Network within the well-child care visits between 0-36 months of infants age (AIM 3);

e. Develop evidence-based practices and/or guidelines for the early detection of ASD/NDDs in the NICU-follow-up services (AIM 3);

f. Training programs for kindergarten teachers and professionals in graduate schools of child neuropsychiatry, neonatology, and pediatrics (AIM 3).

Once recruitment and clinical surveillance (estimated time: 23 mo) will be completed and sample size reached, the database will be closed and primary and secondary outcome measures analyzed with the goal of building a predictive model, and considering, as independent variables, clinical/behavioral/biological measures collected at each timepoint.

Statistical analysis

We will perform analyses of variance (ANOVAs) on clinical infants' outcomes obtained at each timepoint with group (4 levels: siblings of children with ASD, preterm, SGA, and LR infants) as the main between-factor variable. Differences among groups (ASD siblings/preterm/SGA infants with or without a diagnosis of ASD/NDDs) will be analyzed using t-test or ▇▇▇▇-▇▇▇▇▇▇▇ (▇▇▇▇▇▇▇▇-Wallis) test - depending on data distribution - for continuous variables and chi square or ▇▇▇▇▇▇'▇ exact probability test for categorical variables.

Additionally, models to track early developmental trajectories will be estimated in Mplus by latent class growth analysis with inter-individual variations in time of assessment and mixed-effects linear models with repeated measures to assess group differences in rates of longitudinal clinical changes. Cluster analysis will be used to detect infant subgroups with similar developmental patterns. Longitudinal trajectories of primary outcome variables will be modeled using generalized linear mixed models (GLMMs) with main effects of ASD/NDD outcomes at 36 months and time points along with their 2-way interactions. All available observations from each participant will be used in modeling via the GLMM. The GLMM will account for correlations between repeated measures within individuals, allowing for fixed and time-varying covariates and automatically handling missing data, thereby producing unbiased estimates if observations are missing at random.

A model will be implemented to predict ASD/NDD outcomes based on both clinical and experimental measures (AIM 3). Both classic statistical approaches (e.g., logistic regressions and generalized linear models) and machine learning algorithms (e.g., Support Vector Machine, Random Forest, and Extreme Gradient Boosting) will be applied. Machine learning models will be trained on a subset of the sample and then tested in the remaining subset. Predictive performance of the models will be mainly measured using the receiving operating characteristic (ROC) curve analysis. The predictive performance of the different models will be compared with the DeLong method for comparison of area under curve.

Motor, vocal and social features, EEG/ERP parameters and molecular variables collected in the first year of infants' life will be associated with ASD/NDD symptoms and related traits at 18, 24 and 36 months. Putative prognostic indexes of ASD/NDDs and their predictive power will be identified by multivariate logistic regression and ROC curve analyses.

Sensitivity and specificity (for the detection of ASD/NDDs) and predictive accuracy (for the prediction of ASD/NDD outcome) of the identified prognostic indexes will be evaluated, comparing: (i) HR-ASD vs LR, (ii) HR-NDD vs LR, (iii) HR- no diagnosis vs LR; (iv) HR-ASD vs HR-NDD.

Multivariable predictive model to predict ASD/NDDs will be obtained by carrying out logistic regression modeling. Odds ratios (ORs) and 95% confidence intervals (CI) will be obtained. A probabilistic score will be obtained by considering significant variables and its prognostic accuracy will be evaluated by ROC curve analysis. Sensitivity, specificity, positive predictive value, and negative predictive value will be calculated.

Timing of analysis data

Duration of the study: 24 months.

Mo 0-2: Submission of the documents for the Ethics Committee evaluation (UO1); kick-off meeting; recruitment of under 40 and secondary collaborators; training of all the professionals involved in the surveillance protocol and telehealth support; ordering clinical tests, equipment and supplies for biological sampling and analyses; preparing and submitting the standard operative procedures (SOPs);

Mo 0-3: Development of the BABY@NET digital platform;

Mo 3-15: Once the study is approved by the UO1 Ethics Committee, recruitment will be implemented at UOs involved in the project and continue until month 15 (or until the appropriate number of infants will be reached);

Mo 3-6: UO2 and UO4 recruitment of LR and preterm infants for the pilot study; collection of cord blood and first meconium sampling at birth;

Mo 3-24: All LR and HR infants recruited by BABY@NET and the NIDA Network, also for the pilot study, will undergo a comprehensive clinical/experimental assessment; Telehealth support activation: data entry and audio/video/test scoring and analyses;

Mo 9: Interim analysis to assess the recruitment progress; Mo 12: Interim analysis of preliminary data;

Mo 9-18: Analyses of biological samples;

Mo 9-24: Analyses of clinical/experimental data;

Mo 18-24: Predictive model building, statistical analysis and machine learning on clinical/experimental and biological data; Mo 22-24: Final report and dissemination (e.g., conferences, publication of the data) performed by all UOs.

5.6 Expected outcomes

The main expected outcome of the present project proposal is to set up and validate an easy-to-perform, feasible and specific multi-observational protocol for the early identification of ASD and other NDDs in siblings of children with ▇▇▇, SGA and infants born preterm. Anticipating the diagnosis process will allow children to be included in individualized early intervention programs and improve their clinical outcome and quality of life.

The present project will enable to:

1. endorse the detection of: a) at 12 months, the degree of risk of developing NDDs and ASD, allowing primary healthcare practitioners to orient parents towards timely diagnostic evaluation; b) at 18 months, a first diagnosis, fostering a timely decision on the start of intervention(s); c) at 24 months, a stable and reliable diagnosis accompanied by targeted and personalized intervention(s).

2. track developmental trajectories in the first year of life (in different behavioral domains: motor, language, sensory, and social) over time and in different HR populations, allowing us to better describe the heterogeneity of ASD/NDDs.

2. guarantee the full implementation of a validated protocol in all the CPUs and NICUs follow-up of the NHS.

3. establish a network between the CPUs and NICUs involved in the present proposal. The interdisciplinary teams will work collaboratively to achieve the common goal of improving the care, service delivery, and long-term outcomes of HR infants and their families. Together with supporting the development of a digital platform that will permit sharing of best practices, opinions and experiences on illustrative and novel clinical case reports, unusual observations, and adverse responses to therapies among professionals of the Italian territory.

4. sustain CPUs and NICU's teams to improve neurodevelopmental outcomes and face clinical challenges of HR infants and their families by the creation of evidence-based practices, guidelines and training programs on follow-up services for the early detection of ASD/NDDs. These guidelines will inform future policymakers and reinforce the development of novel cost-effective follow-up programs.

5. identify a set of genetic/epigenetic, metabolomic and secretome biomarkers that will contribute to advanced knowledge in the pursuit of robust markers of disease and clinical outcomes. We will select predictive and prognostic markers of NDDs/ASD to set up a sensitive observational/clinical/biological protocol to be applied in the neonatal nurseries and in intensive- and primary-care settings.

5.7 Risk analysis, possible problems and solutions

The present research does not involve risk or discomfort for children and their families. However, the following critical

aspects may arise:

1) Recruitment. A potential issue concerns the participants' drop-out in longitudinal studies. However, based on our sample already followed up within the NIDA Network (only 2 infants have dropped-out since 2010), we expect to attain a 5% drop- out rate in this study. UO2, UO3 and UO4 are tertiary centers for ASD/NDD diagnosis/intervention welcoming >1,000 ASD children per year and specialized centers for preterm deliveries/births (average number of preterm infants < 32 GA is around 150 per year each UO). All centers present an extensive experience in performing clinical trials and observational/experimental studies. If the estimated number of ASD children will not be reached by the UOs involved in the project, the recruitment will be surely supported by the CPUs of the ASL Roma 1 and 2 with a catchment area of more than 500,000 children each and the CPUs/NICUs of the NIDA Network coordinated by UO1 (at the National Level) and UO3 in Lombardy and Campania Regions.

2) Compliance. Contact with families will be ensured to monitor the adherence to the clinical/experimental protocol and occurrence of adverse events will be taken care of by clinicians promptly. Also, dropouts will be reduced by the clinicians' prompt intervention. Contact with families will be ensured ongoing by phone calls/video-calls, emails, or in-person visits.

3) Identification of diagnostic predictors. In case of difficulties in identifying diagnostic predictors due to high inter-individual variability, we will increase the sample size by expanding the catchment area for recruitment.

4) Adherence to the protocol. Specific SOPs will be defined to harmonize the conduction of the study and protocol integrity. Two-day training course will be organized for all professionals involved in the project to ensure adherence to the protocol. Should any problem arise during the project, an advisory board composed by ▇▇▇ principal collaborators and professionals of the European Clinical Research Infrastructure at ISS will be consulted.

5) Experimental procedures. EEG+ET are noninvasive techniques, and every precaution will be taken to avoid discomfort for the infants and their families. Possible problems may arise from the infant's movement and difficulty in completing the calibration procedure. The experimenter may manually pause the start of the trial when the infant moves, and if the child encounters difficulties during the experimental recordings, the experimenter will ask the parent's support.

The following strategies will be taken to minimize or avoid biases:

1) All the data will be recorded anonymously and entered into the BABY@NET secure digital platform by each UO. Completeness of data regarding the primary and secondary outcome measures will be monitored during the study to reduce the number of missing data. Data will be stored at UO1's server for the time necessary for the purpose and/or for possible reuse in related and similar projects/studies/protocols and in any case not incompatible with the reasons for collection. Data will be processed in compliance with the provisions of the European Data Protection and Privacy Regulation (EU Reg. 2016/679 - G.D.P.R.) in both the collection and use and transmission of the data.

2) Specific SOPs will be elaborated and disseminated within the UOs to harmonize the conduction of the study and protocol integrity. Major deviations from clinical/experimental procedures will be detailed to allow assessment of adherence to the study protocol.

5.8 Significance and Innovation

Early identification of ASD/NDDs is crucial in light of findings indicating that early behavioral intervention is much more effective than interventions starting in later childhood, resulting in a long-term reduction of costs for the NHS. The establishment of an easy, feasible, affordable and multi-observational protocol, including a set of clinical tests and innovative technologies, will improve the detection of early signs of ASD/NDDs in at-risk populations. In addition, telehealth support will enable CPUs/NICUs to take advantage of skills not currently present in the team and relieve the burden of professionals through online data entry, scoring and analysis. CPUs/NICUs will be connected in a network sharing information and best practices on very early detection of NDDs. This strategy will lead to early behavioral intervention limiting the impact of symptomatology and resulting in increased quality of life for infants and their families and long-term reduction of NHS costs.

5.9 Bibliography

▇▇▇▇▇▇▇▇▇▇ et al. Brain Sci 2020; 10(4):203 ▇▇▇▇▇▇▇▇ et al. JAMA Pediatr 2014; 168(8):721-8

▇▇▇▇▇▇ et al. Psychiatr Danub 2021; 33(suppl 11):65-68 ▇▇▇▇▇▇ et al. Brain Sci 2020; 10(6):379

▇▇▇▇▇▇▇▇▇ et al. J Autism Dev Disord 2021; 51(11):3829-3842 Crucitti et al. Autism 2020; 24(7):1726-1739

Dall'Aglio et al. Neurosci Biobehav Rev 2018; 94:17-30 Di ▇▇▇▇▇▇▇ et al. Sci Rep 2016; 6:26395

Di ▇▇▇▇▇▇▇ et al. Sci Rep 2021; 11(1):15785 Dow et al. Autism Res 2020; 13(1):122-133 Fontana et al. BMC Med 2021; 19(1):42 ▇▇▇▇ et al. Ann Transl Med 2019; 7(23):792 Loke et al. Front Neurol 2015; 6:107 ▇▇▇▇▇▇▇▇▇ et al. Front Psychiatry 2020; 11:91

Marchi et al. Acta Paediatr 2019; 108(10):1817-1824 ▇▇▇▇▇ et al. Neurosci Biobehav Rev 2020; 116:183-201 ▇▇▇▇▇▇▇ et al. Biol Psychiatry 2021; 89(5):451-462 ▇▇▇▇ et al. J Child Psychol Psychiatry 2011; 52(5):588-98 Purpura et al. Front Psychol 2017; 8:1168

▇▇▇▇▇ et al. BMJ 2020; 368:m441 Riva et al. Sci Rep 2018; 8(1):1-11

▇▇▇▇ et al. Autism Res 2021; 14(7):1421-1433 ▇▇▇▇ et al. Infancy 2022; 27(2):369-388 ▇▇▇▇▇▇▇ et al. Nat Commun 2020; 11(1):2703

▇▇▇▇▇ et al. J Autism Dev Disord. 2017; 47(7):2108-2119 ▇▇▇▇▇▇ et al. Autism Res 2022; 15(5):778-790

5.10 Timeline / Deliverables / Payable Milestones

Surveillance: experimental/clinical protocol

Mo 0-2: Ethics approval, kick-off meeting, personnel recruitment, training, ordering materials, SOPs Mo 0-3: BABY@NET digital platform development

Mo 3 - DELIVERABLE 1: Digital platform and telehealth support running Mo 3-15: LR and HR newborns/infants enrollment

Mo 3-24: LR and HR infants clinical/experimental assessment, data entry and activation of telehealth support services

Pilot study

Mo 3-6: LR and preterm infants recruitment (UO2, UO4), cord blood and first meconium sampling Mo 3-24: LR and preterm infants clinical/experimental assessment

Analyses

Mo 9-18: Biological samples analyses

Mo 9-24: Clinical/experimental data analyses

Mo 9 - DELIVERABLE 2: Interim analysis to assess the recruitment progress Mo 12 - DELIVERABLE 3: Interim analyses (preliminary data)

Mo 18-24: Predictive model building, statistical analysis and machine learning on data collected Mo 22-24: Final report/dissemination

Mo 23-24: DELIVERABLE 4: Final report

Milestones 12 month

M1) Approval by the ethics committee and definition of SOPs M2) Implementation of the BABY@NET platform

M3) LR and Preterm infants recruitment for the Pilot study completed M4) Finalization of preliminary analysis

Milestones 24 month

M1) LR and HR infants recruitment completed

M2) Finalization of statistical analysis on clinical/experimental and biological data

M3) Identification of early markers associated with ASD/NDD and/or with specific ASD/NDD related-traits M4) Predictive model built and validated (positive and negative predictive values)

M5) Dissemination of the results (reports, publications, congress/webinar oral presentation)

Gantt chart

GANTT PNRR 2022 def.png

5.11 Equipment and resources available

Facilities Available

UO1 is the leading technical and scientific public body of the Italian NHS. UO1 implemented a digital platform to support research activities for the NIDA Network allowing anonymous and standardized data collection of the clinical-diagnostic protocols for the surveillance of HR and LR infants (▇▇▇▇▇://▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇.▇▇/). Resources/Tools available: equipment for audio/video recording and analysis, statistical analysis softwares (i.e., SPSS, SAS and STATA), xMAP technology on the X200 Luminex platform equipped with analytical software (Manager 6.1).

UO2 is a third-level center for clinical care (6,000 newborn infants/year). It provides specialized care to preterm and term newborns with 23 cots for NICU, 50 for special care and 60 for healthy term babies. Follow-up services provided to preterm/SGA newborns at major neurological risk (3,000 visits/year). Resources/Tools available: EEG services (Neurophysiopathology - Pediatric Section); epigenetic analysis (INGM - Genome Biology Unit led by Prof. Bodega) by 3 analyser FACS, 2 Cell sorter FACSaria III, Illumina system for genomics and the MICRORGRID (Genomic Solution) for proteomics; Bioinformatics: research-IT infrastructure to high performance computing with an in-house cluster of 400 CPUs (AMD Opteron), 1.5TB RAM, 90TB storage on a 10 Gigabit connectivity.

UO3 includes 27 centers with about 2,000 professionals and 20,000 patients/year; reference NIDA center for the HR populations in Lombardy Region. Resources/Tools available: Babylab to record responses to experimental stimuli and parent-child behaviors in real-time interactions, E-Prime-3, SPSS, R, Mplus, Matlab, EEGLAB/ERPLAB, EEG-EYE, ProLab; EEG system with 64-channel and 128-channel sensor nets.

UO4 hosts 5,000 visits and around 300 hospitalizations per year in the day hospital and outpatient clinic, 3 rooms dedicated to hospitalized patients; regional reference center for Rett syndrome, ADHD, child psychiatric emergencies and complex ASD cases. Resources/Tools available: EEG, EU certified bio-banking facilities, advanced technologies for metagenomics and metabolomics studies (HPLC, GC-MS, MALDI-TOF), flow cytometry, cell-sorter, microarray and Real Time PCR, specific software for biostatistics and Artificial Intelligence tools (Task Force on Microbiome Studies).

Subcontract

Subcontracts for digital platform development (UO1), gut metagenome (UO4) and GATC/Eurofins genomics (UO2) services to ensure the most up-to-date sequencing technology.

5.12 Desc. of the complementarity and sinergy of secondary collab. researchers

The professionals involved in BABY@NET project are among the most experienced nationwide experts in different complementary domains concerning perinatal care, clinical assessment and management of NDDs (early detection, behavioral assessment), coordination of surveillance networks and data analysis, exploration and identification of specific immunology, electrophysiology, genetic and epigenetic biomarkers. The synergy of the research team stands on the already established NIDA Network, the largest multi-center and multi-disciplinary network in Italy, aimed to guide observational studies and surveillance programs for early detection of ASD/NDDs. It works in collaboration with national and international professionals, scientific organizations, public and academic institutions. The great scientific relevance of the NIDA Network relies on measurements and tools to monitor the central nervous system development and child health in a non-invasive way. The NIDA clinical-diagnostic evaluation protocols have been implemented as a system action of all Regions and Autonomous Provinces in the Italian territory aimed at the surveillance of 0-3 years old children and implementation of services dedicated to the diagnosis, care, and treatment of people with ASD. So far, in Italy 193 clinical centers (148 CPUs and 45 NICUs) have been activated as NIDA sentinel centers and are adopting the NIDA Network clinical protocol. Researchers, clinicians and therapists belonging to our UOs will support project activities, but will not burden the project financially.

Given the important working hypothesis of this project and the limited time to carry out its activities, dedicated personnel (second collaborators) with complementary skills to the research collaborators will be recruited from our OUs to support participation in clinical and research tasks. In particular, they will recruit families, assess newborns/infants, perform data- entry, process and analyze biological samples (genetic and epigenetic, metabolomic, secretome) and statistical data. Those collaborators will work in synergy with the principal collaborators and under-40 researchers hired ex-novo through the present proposal.

Second collaborators will be recruited for 12-18 months as follows:

in the UO1: 1 researcher to support the co-PI in performing BABY@NET statistical analysis

in the UO2: 1 researcher/clinical consultant for the recruitment and testing of premature and/or SGA infants, video/audio recording, data collection and analysis of cry, vocal, motor performances in the NICU and at the Follow-up service of at high-risk infants; 1 researcher to support ▇▇▇▇. ▇▇▇▇▇▇▇▇▇ in the epigenetic analyses that will be performed by the laboratory of Genome Biology Unit, INGM and in data interpretation

in the UO3: 2 researchers/clinical consultants to support Dr. Riva in high-risk infants recruitment and assessment, data collection and analysis of experimental parameters, data entry and tests scoring

in the UO4: 1 researcher to support ▇▇▇▇. ▇▇▇▇▇ ▇▇▇▇▇▇, at the ImmunoNutritionLab of the Maternal and Child Health Dept. in the biological samples processing and metabolomic analysis; 1 child psychiatrist for EEG data collection and analyses

The principal collaborators, with an extensive experience of doctoral and postdoctoral trainings supervision focused on prematurity-related long-term outcomes and neurodevelopmental disorders, will guarantee the synergy of the entire working group.

5.13 Translational relevance and impact for the national health system (SSN)

What is already know about this topic?

The prevalence of ASD, other NDDs, SGA and survival rates of preterm (accounting for 11% of all live births), have increased considerably in recent years. Siblings of ASD children, infants born preterm or/and SGA are at higher risk for developing ASD or other NDDs compared to the general population. Despite knowing that early signs of the disorders are visible in the first year of life, the diagnosis is made around age 4-5. The severity of delayed diagnosis becomes even more serious considering the lack of intervention at a developmental stage when brain plasticity is at its highest. Since 2010, the NIDA Network has promoted the surveillance of at-risk infants using a clinical protocol at 6-36 months, but the limited human and economic resources of the NHS have constrained its homogeneous diffusion in all NICUs and CPUs of the Italian territory.

Zwaigenbaum L, ▇▇▇▇▇▇ M. (2018). Autism spectrum disorder: advances in diagnosis and evaluation. BMJ. 361:k1674. doi: 10.1136/bmj.k1674.

Details on what is already know about this topic

▇▇▇▇▇ and targeted intervention improves future clinical outcomes and quality of life for children and families. Testing different behavioral domains (motor, language, sensory, and social) and tracking infant developmental trajectories in the first year of life, over time and in different HR populations, will allow us to identify early markers of ASD/NDDs and describe the heterogeneity of those conditions.

The NIDA Network guides national observational studies and surveillance programs for the early detection of ASD/NDDs and works in collaboration with national and international scientific organizations, public and academic institutions. It has published scientific papers collecting data by noninvasive innovative technologies to monitor the infant central nervous system development and behavior. BABY@NET project will benefit from NIDA's activities and collaborations by using the know-how gained so far in selecting innovative tests and technologies to identify early ASD/NDDs markers.

What this reasearch adds?

BABY@NET will empower the NIDA Network clinical protocol with a feasible and affordable high-tech research protocol, including innovative tests and technologies. We will also collect non-invasive biological samples at birth in preterms and perform genetic, epigenetic, metabolomic, and secretome analyses to provide putative markers for early identification of children at-risk for ASD/NDDs and dissecting their role in etiology.

Centralized telehealth support provided to NICUs and CPUs for test scoring and audio/video analysis will compensate for the lack of personnel and expertises necessary for performing clinical/experimental assessment and ensure the protocol's dissemination. Bioinformatic analyses will be performed on the full dataset for predictive risk factors identification within the first year of life.

▇▇▇▇▇▇ A & ▇▇▇▇▇▇▇ JD (2021). The promise of precision medicine in autism. Neuron. 109(14):2212-2215. doi:10.1016/j.neuron.2021.06.025.

Details on what this reasearch adds

The BABY@NET project will help identify behavioral, biological, and neurophysiological markers with high predictive value that will anticipate the diagnosis of ASD/NDD in infants younger than 18-24 months of age. The BABY@NET project will support families with siblings already diagnosed with ASD, with infants born preterm/SGA and infants who show early atypia, by providing the leading Italian professionals in the early detection and diagnosis of ASD/NDD. The digital platform will also make it possible to collect a large amount of data of typical infants/toddlers, which can also be used to generate normative data in the future. The dissemination of the results will be implemented within the international scientific community (international conferences and peer-reviewed international journals) and within the national and local professional/clinical community to promote the protocol and the telehealth support with the final aim to expand the best practices at the national level.

What are the implications for public health, clinical practice, patient care?

1) Public health: the implementation of the BABY@NET protocol in the NICUs/CPUs will ensure a specialized neurodevelopmental assessment that could be extended to other at-risk populations (i.e infants with fetal alcohol syndrome or born from mothers with pre- or postpartum psychiatric disorders).

2) Clinical practice: the BABY@NET protocol will be transferred to the whole national territory by the development of an IT system for the clinical/experimental data collection and analysis and tele-health support of experienced NHS professionals.

3) Patient care: BABY@NET will entail detecting infants at risk in the first year of life for their prompt enrollment in individualized treatments aimed at modifying the course of early behavioral and brain development, significantly improving quality of life and functional independence.

▇▇▇▇ et al. (2022). The Lancet Commission on the future of care and clinical research in autism. Lancet. 399(10321):271- 334. doi:10.1016/S0140-6736(21)01541-5.

Details on what are the implications for public health, clinical practice, patient care

The implications of the BABY@NET project will continue after the end of the 24-month funded period. Thanks to the already established NIDA Network, the surveillance protocol will continue to be applied in all NICUs and CPUs of the Italian territory. The digital platform will ensure the security and accuracy of data and the implementation of follow-up services in clinical practice. Savings in personnel and material costs will result in improved public services delivery.

Our BABY@NET project will be beneficial for other at-risk populations: infants exposed to prenatal alcohol or infants born from mothers with pre- or postpartum psychiatric disorders. They are exposed to a myriad of prenatal and postnatal risk factors that contribute to the emergence of developmental flaws (e.g., motor, cognitive and language problems) and NDDs. Thanks to our very thorough neurodevelopmental assessment, also infants born in disadvantaged situations will benefit from early targeted interventions.

6 - Budget

Total proposed budget ( Euro )
Costs	TOTAL BUDGET	Co-Funding	List of costs proposed for funding to the MOH	Percentage of total proposed to the MOH
1 Staff Salary	186.377,00	186.377,00	not permitted	0,00
2 Researchers' Contracts	537.000,00	0,00	537.000,00	55,08
3a.1 Equipment (Leasing -	48.500,00	5.000,00	43.500,00	4,46
3a.2 Equipment (buying)	38.000,00	21.000,00	17.000,00	1,74
3b Supplies	212.140,00	0,00	212.140,00	21,76
3c Model Costs	0,00	0,00	0,00	0,00
4 Subcontracts *	43.500,00	0,00	43.500,00	4,46
5 Patient Costs	0,00	0,00	0,00	0,00
6 IT Services and Data Bases	13.000,00	0,00	13.000,00	1,33
7 Travels	16.950,00	0,00	16.950,00	1,74
8 Publication Costs	16.500,00	0,00	16.500,00	1,69
9 Dissemination	5.000,00	0,00	5.000,00	0,51
10 Overheads *	60.410,00	0,00	60.410,00	6,20
11 Coordination Costs	10.000,00	0,00	10.000,00	1,03
Total	1.187.377,00	212.377,00	975.000,00	100,00

* percentage calculated as average value between all the Operating Units.

Report the Co-Funding Contributor:

UO1: A certain amount of audio and video recording equipment that will be used in the present project has been purchased through the Project H2020 - ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ International Training Network SAPIENS: a collaborative network funded through the European Committee. Total amount: € 239.899

UO1-2-3-4: Infant clinical assessment will be partially supported by collaborators paid by the Ministry of Health Project- Autism Fund 2018: NIDA Network between pediatricians, child psychiatrist, neonatologists of the National Health System. Total amount: € 547.484

Budget Justification
1 Staff Salary	UO1: PI and co-PI (10 months/2 years); UO2: Principal collaborator and Collaborator (10 months/2 years); UO3: Principal collaborator and collaborator (14 months/2 years); UO4: Principal collaborator and Collaborator (10 months/2 years)

2 Researchers' Contracts	UO1-UO4: 3 under-40 research contract (2 years each); UO1-UO2-UO3-UO4: 6 research contract for 12-18 months; UO2: 1 Ph.D. research fellow for 18 months
3a.1 Equipment (Leasing - Rent)	UO1: equipment for spontaneous and intentional motor movements (Depth Camera and wireless accelerometers) and for infant crying spectrographic recordings; UO2 and UO4: Eye-tracker system for 18 months; UO4: personal computers
3a.2 Equipment (buying)	UO2: EEG nets, materials for audio-video recordings; UO3: EEG: nets and testing materials
3b Supplies	Consumables for metabolomic/inflammatory/secretome analyses, for EEG and eye tracking recordings, materials for scoring test
3c Model Costs	-
4 Subcontracts	UO1: BABY@NET digital platform development; UO2-UO4: Services for GATC/Eurofins genomics and metabolomics
5 Patient Costs	-
6 IT Services and Data Bases	UO2-UO3: software licenses and bioinformatics tools
7 Travels	UO1-UO2-UO3-UO4: Travel expenses for meetings between operative units
8 Publication Costs	UO1-UO2-UO3: Costs for publication in open-access journals
9 Dissemination	UO3 Expenses to present the results in national and international congresses (congress registration costs)
10 Overheads	UO1-UO2-UO3-UO4: Institutional overhead 7%
11 Coordination Costs	UO1: Organization of two meetings/year for exchange of information and discussion of results and the final conference

Proposed total budget UO1 Institution: Istituto Superiore di Sanita' (Euro)

Costs	TOTAL BUDGET	Co-Funding	List of costs proposed for funding to the MOH	Percentage of total proposed to the MOH
1 Staff Salary	46.720,00	46.720,00	not permitted	0,00
2 Researchers' Contracts	104.000,00	0,00	104.000,00	59,81
3a.1 Equipment (Leasing - Rent)	17.500,00	5.000,00	12.500,00	7,19
3a.2 Equipment (buying)	0,00	0,00	0,00	0,00
3b Supplies	16.500,00	0,00	16.500,00	9,49
3c Model Costs	0,00	0,00	0,00	0,00
4 Subcontracts	13.500,00	0,00	13.500,00	7,76
5 Patient Costs	0,00	0,00	0,00	0,00
6 IT Services and Data Bases	0,00	0,00	0,00	0,00
7 Travels	2.500,00	0,00	2.500,00	1,44
8 Publication Costs	4.500,00	0,00	4.500,00	2,59
9 Dissemination	0,00	0,00	0,00	0,00
10 Overheads	10.370,00	0,00	10.370,00	5,96
11 Coordination Costs	10.000,00	0,00	10.000,00	5,75
Total	225.590,00	51.720,00	173.870,00	100,00

Budget Justification
1 Staff Salary	PI (6 months/2 years), co-PI (4 months/2 years)
2 Researchers' Contracts	1 full-time research contract for the under-40 (2 years) for biological sampling and secretome/inflammatory analyses; 1 full-time research contract for a biostatistician (1 year) to monitor adherence to protocol and statistical analysis.
3a.1 Equipment (Leasing - Rent)	Equipment for spontaneous and intentional motor movements (Depth Camera and wireless accelerometers) and for infant crying spectrographic recordings (TASCAM)
3a.2 Equipment (buying)	-
3b Supplies	Consumables for secretome/inflammatory analysis, materials for scoring test
3c Model Costs	-
4 Subcontracts	Service costs for the BABY@NET digital platform development
5 Patient Costs	-
6 IT Services and Data Bases	-
7 Travels	Travel expenses for meetings between operative units
8 Publication Costs	Costs for publication in open-access journals
9 Dissemination	-
10 Overheads	Institutional overhead 7%
11 Coordination Costs	Organization of two meetings per year to exchange information and discussion of results and final conference

Proposed total budget UO2 Institution: Fondazione IRCCS Policlinico Ca' Granda (Euro)

Costs	TOTAL BUDGET	Co-Funding	List of costs proposed for funding to the MOH	Percentage of total proposed to the MOH
1 Staff Salary	40.612,00	40.612,00	not permitted	0,00
2 Researchers' Contracts	95.000,00	0,00	95.000,00	44,37
3a.1 Equipment (Leasing - Rent)	15.000,00	0,00	15.000,00	7,01
3a.2 Equipment (buying)	8.000,00	0,00	8.000,00	3,74
3b Supplies	68.000,00	0,00	68.000,00	31,76
3c Model Costs	0,00	0,00	0,00	0,00
4 Subcontracts	5.000,00	0,00	5.000,00	2,34
5 Patient Costs	0,00	0,00	0,00	0,00
6 IT Services and Data Bases	2.000,00	0,00	2.000,00	0,93
7 Travels	2.450,00	0,00	2.450,00	1,14
8 Publication Costs	5.000,00	0,00	5.000,00	2,34
9 Dissemination	0,00	0,00	0,00	0,00
10 Overheads	13.650,00	0,00	13.650,00	6,38
11 Coordination Costs	not permitted	not permitted	not permitted	0,00
Total	254.712,00	40.612,00	214.100,00	100,00

Budget Justification
1 Staff Salary	Principal collaborator (2 months/year), Collaborator (3 months/year)
2 Researchers' Contracts	1 researcher for 18 months for recruitment and testing of preterm and SGA infants in the NICU; 1 Ph.D. research fellow for 18 months with expertise in molecular biology, genomics, NGS experiments for the LINE1 promoter methylation analysis.
3a.1 Equipment (Leasing - Rent)	Eye-tracker system for 18 months
3a.2 Equipment (buying)	EEG nets, materials for audio-video recordings
3b Supplies	Supplies for EEG and eye tracking recordings, genomic/methylation consumables, materials for test scoring
3c Model Costs	-
4 Subcontracts	Services at GATC/Eurofins genomics (e.g. primers, sequencing)
5 Patient Costs	-
6 IT Services and Data Bases	Software for data analysis
7 Travels	Travel expenses for meetings between operative units
8 Publication Costs	Costs for publication in open-access journals
9 Dissemination	-
10 Overheads	Institutional overhead 7%
11 Coordination Costs	-

Proposed total budget UO3 Institution: IRCCS Medea (Euro)

Costs	TOTAL BUDGET	Co-Funding	List of costs proposed for funding to the MOH	Percentage of total proposed to the MOH
1 Staff Salary	46.125,00	46.125,00	not permitted	0,00
2 Researchers' Contracts	105.000,00	0,00	105.000,00	53,57
3a.1 Equipment (Leasing - Rent)	0,00	0,00	0,00	0,00
3a.2 Equipment (buying)	30.000,00	21.000,00	9.000,00	4,59
3b Supplies	42.500,00	0,00	42.500,00	21,68
3c Model Costs	0,00	0,00	0,00	0,00
4 Subcontracts	0,00	0,00	0,00	0,00
5 Patient Costs	0,00	0,00	0,00	0,00
6 IT Services and Data Bases	11.000,00	0,00	11.000,00	5,61
7 Travels	4.000,00	0,00	4.000,00	2,04
8 Publication Costs	7.000,00	0,00	7.000,00	3,57
9 Dissemination	5.000,00	0,00	5.000,00	2,55
10 Overheads	12.490,00	0,00	12.490,00	6,37
11 Coordination Costs	not permitted	not permitted	not permitted	0,00
Total	263.115,00	67.125,00	195.990,00	100,00

Budget Justification
1 Staff Salary	Principal collaborator (2 months/year), Under 40 collaborator (5 months/year)
2 Researchers' Contracts	2 full-time research contracts for 18 months for experimental and clinical surveillance
3a.1 Equipment (Leasing - Rent)	-
3a.2 Equipment (buying)	EEG: nets and testing materials
3b Supplies	Consumables for EEG and eye tracking recordings
3c Model Costs	-
4 Subcontracts	-
5 Patient Costs	-
6 IT Services and Data Bases	Software licenses; software and bioinformatics tools
7 Travels	Travel expenses for meetings between operative units
8 Publication Costs	Costs for publication in open-access journals
9 Dissemination	Expenses to present the results in national and international congresses (congress registration costs)
10 Overheads	Institutional overhead 7%
11 Coordination Costs	-

Costs	TOTAL BUDGET	Co-Funding	List of costs proposed for funding to the MOH	Percentage of total proposed to the MOH
1 Staff Salary	52.920,00	52.920,00	not permitted	0,00
2 Researchers' Contracts	233.000,00	0,00	233.000,00	59,58
3a.1 Equipment (Leasing - Rent)	16.000,00	0,00	16.000,00	4,09
3a.2 Equipment (buying)	0,00	0,00	0,00	0,00
3b Supplies	85.140,00	0,00	85.140,00	21,77
3c Model Costs	0,00	0,00	0,00	0,00
4 Subcontracts	25.000,00	0,00	25.000,00	6,39
5 Patient Costs	0,00	0,00	0,00	0,00
6 IT Services and Data Bases	0,00	0,00	0,00	0,00
7 Travels	8.000,00	0,00	8.000,00	2,05
8 Publication Costs	0,00	0,00	0,00	0,00
9 Dissemination	0,00	0,00	0,00	0,00
10 Overheads	23.900,00	0,00	23.900,00	6,11
11 Coordination Costs	not permitted	not permitted	not permitted	0,00
Total	443.960,00	52.920,00	391.040,00	100,00

Proposed total budget UO4 Institution: Azienda Ospedaliera Universitaria ▇▇▇▇▇▇▇▇ ▇▇, Regione Campania (Euro)

Budget Justification
1 Staff Salary	Principal collaborator (2 months/year), Collaborator (3 months/year)
2 Researchers' Contracts	2 full-time research contracts for the under-40 (2 years each) for recruitment, EEG-ET experimental/clinical data collection; telehealth support; biological sampling and stool metabolomic analyses; 2 researchers' contract for 12-18 months
3a.1 Equipment (Leasing - Rent)	Eye-tracker system for 18 months, personal computers
3a.2 Equipment (buying)	-
3b Supplies	Consumables and reagents for metabolomic analyses, materials for scoring test
3c Model Costs	-
4 Subcontracts	Services for metabolomics analysis
5 Patient Costs	-
6 IT Services and Data Bases	-
7 Travels	Travel expenses for meetings between operative units
8 Publication Costs	-
9 Dissemination	-
10 Overheads	Institutional overhead 7%
11 Coordination Costs	-

Principal Investigator Data

Cognome: SCATTONI Nome: ▇▇▇▇▇ ▇▇▇▇▇

Genere: F

Codice fiscale: ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇

Documento: Carta d'identità, Numero: CA20434FS Data di nascita: 22/08/1973

Luogo di nascita: Tivoli Provincia di nascita: RM

Indirizzo lavorativo: Viale Regina ▇▇▇▇▇ 299 Città: Roma

CAP: 00161

Provincia: RM

Email: ▇▇▇▇▇▇▇▇▇▇.▇▇▇▇▇▇▇▇@▇▇▇.▇▇ Altra email: ▇▇▇▇▇▇▇▇@▇▇▇▇▇.▇▇▇ Telefono: ▇▇▇▇▇▇▇▇▇▇▇▇▇

Altro telefono: ▇▇▇-▇▇▇▇▇▇▇ Qualifica: Ricercatore

Struttura: Servizio di Coordinamento e Supporto alla Ricerca Istituzione: Istituto Superiore di Sanità

Datore/ente di lavoro? Yes Datore/ente di lavoro SSN? Yes Nome datore/ente di lavoro non SSN:

Nome istituzione SSN: Istituto Superiore di Sanità

Tipo contratto: Lavoro Subordinato a Tempo Indeterminato

Con l'invio della presente proposta si dichiara che la stessa o parti significative di essa non sono oggetto di altri finanziamenti pubblici o privati e che di conseguenza vi è assenza del c.d. doppio finanziamento ai sensi dell'art. 9 del Regolamento (UE) 2021/241, ossia che non ci sia una duplicazione del finanziamento degli stessi costi da parte di altri programmi dell'Unione, nonché con risorse ordinarie da Bilancio statale.

By submitting this proposal, I declare that no significant part or parts of it are recipient of any other public or private funding and that consequently there isn't any so-called double financing pursuant to art. 9 of Regulation (EU) 2021/241, i.e. that there is no duplication in the financing of the same costs by other Euopean Union programs or any other ordinary resources from the State budget.

Project validation result

NIDA surveillance network: Numbers of CPUs and NICUs operative

Early language trajectories from 12 to 24 months in ASD siblings

Early developmental trajectories in low- and high-risk populations

Numbers of children recruited

% of diagnoses found in the 349 3-year-old-siblings enrolled

▇▇▇▇▇▇▇▇▇▇ W, ▇▇▇▇▇▇▇▇▇▇ M, ▇▇▇▇▇▇▇▇▇ V, ▇▇▇▇▇▇▇ F, ▇▇▇▇▇▇ A, ▇▇▇▇ L, ▇▇▇▇▇▇▇▇ ML. (2020) Movidea: A Software Package for Automatic Video Analysis of Movements in Infants at Risk for Neurodevelopmental Disorders. Brain Sci. 10(4):203. doi: 10.3390/brainsci10040203.

▇▇▇▇▇▇ A, ▇▇▇▇ L, ▇▇▇▇▇▇▇ F, ▇▇▇▇▇▇▇▇ T, ▇▇▇▇▇ M, ▇▇▇▇▇▇▇▇▇▇ W, ▇▇▇▇▇▇▇▇▇▇ M, ▇▇▇▇▇▇▇▇ ML. (2020) Early Motor Development Predicts Clinical Outcomes of Siblings at High-Risk for Autism: Insight from an Innovative Motion-Tracking Technology. Brain Sci. 10(6):379. doi: 10.3390/brainsci10060379.

▇▇▇▇ ▇, ▇▇▇▇▇▇ ▇, ▇▇▇▇▇▇▇▇ ▇, ▇▇▇▇▇▇ ▇, ▇▇▇▇▇▇ S, ▇▇▇▇▇▇▇ M, ▇▇▇▇▇▇▇▇ ML. (2021) Early developmental trajectories of expressive vocabulary and gesture production in a longitudinal cohort of Italian infants at high-risk for Autism Spectrum Disorder. Autism Research 14(7):1421-1433. doi: 10.1002/aur.2493

EEG/ERP responses related to audio-visual sensory integration in siblings of children with ASD and controls at 12 months of age

▇▇▇▇ V, ▇▇▇▇▇▇▇ EM, Dondena C, ▇▇▇▇▇▇ C, Molteni M, Cantiani C. (2022) Atypical ERP responses to audiovisual speech integration and sensory responsiveness in infants at risk for autism spectrum disorder. Infancy 27(2):369-388. doi: 10.1111/infa.12456.