Risk-Benefit-Assessment. Many pediatric surgical centers worldwide routinely perform MFR after enterostomy creation. However, due to a lack of prospective studies the level of evidence showing a benefit of this treatment strategy is low. Although the systematic review by Xxxxxxxxxx et al. [4] showed no complications using this technique, MFR into the distal bowel loop may potentially cause complications such as bowel perforation. The risk for possible complications can be minimized by careful and standardized manipulation of the enterostomies. The local condition of the ostomy will be investigated twice daily. If our hypothesis is confirmed, the postoperative hospital care of infants undergoing ostomy closure will be shortened. The benefits of MFR may include a shorter duration and therefore less side effects of parenteral nutrition. Moreover, an economic benefit through lower costs for TPN and a shorter hospital stay may be reached. The results of the current study may influence the standard of neonatal intensive care. Therefore the potential benefits of MFR outweigh the possible risks of this study. Results of data analyses including all data how to perform MFR will be published. If the results of this study will show significant differences between the intervention group and controls, MFR will become the new standard of care for neonates with enterostomies. In Germany, the current national guideline for neonatal and surgical treatment of necrotizing enterocolitis (NEC) is currently in revision [Leitlinie 024-009: Nekrotisierende Enterokolitis (NEK)]. One of the principal investigators of the study (Prof. Xx. Xxxxxx Xxxxxx) is coauthor of this guideline. If the current study proves the hypothesis that MFR is beneficial for these infants it may not only change the national guideline for the best treatment after enterostomy creation in Germany but in other countries too.
Risk-Benefit-Assessment. Based on the formal risk assessment, the TFNT00 IOL demonstrates a risk profile that is comparable to the FDA-approved ACRYSOF IQ ReSTOR +3.0 Add Power IOL (Model SN6AD1) . Furthermore, it was concluded that the benefits of increased intermediate vision while maintaining visual performance at near distance significantly outweigh the risks of suboptimal surgical outcomes and when the TFNT00 IOL is used in cataract surgery. Potential risks following implantation of both the TFNT00 IOL and the 839MP IOL (Law 2014) include visual disturbances such as glare and halos which are known risks for multifocal IOLs. The benefits of improved near and intermediate vision, when weighed against the risks of visual disturbances, result in a benefit to risk profile that is favorable for the both the test and control IOLs (Law 2014).
Risk-Benefit-Assessment. The Italian study of oral glutathione in CF children did not report any significant adverse events (AE) associated with GSH administration [6]. Hypothetical concerns regarding alteration of levels of GSH, including alterations of immune modulation have been expressed [28], however are unlikely to be apparent in this short term study. Notably, oral glutathione is readily available as a nutritional supplement. The reported risks associated with these supplements are those associated with taking high concentrations of vitamins, primarily gastrointestinal distress. Additionally, there have been rare anecdotal reports of transitory increase of flatulence and hypersensitivity reactions including skin rashes. Glutathione has generally been shown to be poorly absorbed from the GI tract in humans, thus we anticipate that any adverse events related to the study drug are likely to be GI in nature. The planned study will systematically collect information about gastrointestinal symptoms and includes regular monitoring of subjects through study visits and phone calls. The risks associated with the study procedures (blood draws, fecal specimen collection, and spirometry) are minimal. The data from the earlier study of oral glutathione in children with CF showing improved growth and reduced intestinal inflammation is promising, and the safety profile observed to date suggests an appropriate risk/benefit balance for the proposed study.
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