Common use of Inclusion Criteria Clause in Contracts

Inclusion Criteria. 1. Only infants younger than 366 days of age with status post ileostomy or jejunostomy creation (double loop enterostomies and split enterostomies (with mucous fistula)) will be included in the study to create a homogenous cohort of patients with similar diseases (e.g. necrotizing enterocolitis [NEC], focal intestinal perforation [FIP]). Also, infants of this age group are unique in several respects such as the response to parenteral nutrition and its hepatic toxicity resulting into neonatal cholestasis. The ostomy localization is restricted to the jejunum and ileum. Therefore, the cohort of patients shows a similar bowel length for fluid-, vitamin- and electrolyte resorption 2. All patients with meconium ileus are included into the study. If later (required) diagnostics verify cystic fibrosis, the diagnostics as well as the diagnosis need to be documented in the eCRF and in further analysis subgroups will be established. 3. Signed written informed consent obtained by parents/legal guardians and willingness of parents/legal guardians to comply with treatment and follow-up procedures of their child

Appears in 2 contracts

Samples: Study Protocol, Study Protocol

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Inclusion Criteria. β€Œ 1. Only infants younger than 366 days of age with status post ileostomy or jejunostomy creation (double loop enterostomies and split enterostomies (with mucous fistula)) will be included in the study to create a homogenous cohort of patients with similar diseases (e.g. necrotizing enterocolitis [NEC], focal intestinal perforation [FIP]). Also, infants of this age group are unique in several respects such as the response to parenteral nutrition and its hepatic toxicity resulting into neonatal cholestasis. cholestasis The ostomy localization is restricted to the jejunum and ileum. Therefore, the cohort of patients shows a similar bowel length for fluid-, vitamin- and electrolyte resorption 2. All patients with meconium ileus are included into the study. If later (required) diagnostics verify cystic fibrosis, the diagnostics as well as the diagnosis need to be documented in the eCRF and in further analysis subgroups will be established. 3. Signed written informed consent obtained by parents/legal guardians and willingness of parents/legal guardians to comply with treatment and follow-up procedures of their child

Appears in 1 contract

Samples: Study Protocol

Inclusion Criteria. 1. Only infants younger than 366 days of age with status post ileostomy or jejunostomy creation (double loop enterostomies and split enterostomies (with mucous fistula)) will be included in the study to create a homogenous cohort of patients with similar diseases (e.g. necrotizing enterocolitis [NEC], focal intestinal perforation [FIP]). Also, infants of this age group are unique in several respects such as the response to parenteral nutrition and its hepatic toxicity resulting into neonatal cholestasis. The ostomy localization is restricted to the jejunum and ileum. Therefore, the cohort of patients shows a similar bowel length for fluid-, vitamin- and electrolyte resorption. 2. All patients with meconium ileus are included into the study. If later (required) diagnostics verify cystic fibrosis, the diagnostics as well as the diagnosis need to be documented in the eCRF and in further analysis subgroups will be established. 3. Signed written informed consent obtained by parents/legal guardians and willingness of parents/legal guardians to comply with treatment and follow-up procedures of their child.

Appears in 1 contract

Samples: Study Protocol

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Inclusion Criteria. 1. Only infants younger than 366 days of age with status post ileostomy or jejunostomy creation (double loop enterostomies and split enterostomies (with mucous fistula)) will be included in the study to create a homogenous cohort of patients with similar diseases (e.g. necrotizing enterocolitis [NEC], focal intestinal perforation [FIP]). Also, infants of this age group are unique in several respects such as the response to parenteral nutrition and its hepatic toxicity resulting into neonatal cholestasis. cholestasis The ostomy localization is restricted to the jejunum and ileum. Therefore, the cohort of patients shows a similar bowel length for fluid-, vitamin- and electrolyte resorption 2. All patients with meconium ileus are included into the study. If later (required) diagnostics verify cystic fibrosis, the diagnostics as well as the diagnosis need to be documented in the eCRF and in further analysis subgroups will be established. 3. Signed written informed consent obtained by parents/legal guardians and willingness of parents/legal guardians to comply with treatment and follow-up procedures of their child

Appears in 1 contract

Samples: Study Protocol

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