Methods against bias Sample Clauses

Methods against bias. This is an open-label study. Blinding is not possible because active refeeding of stool in the intervention group is obvious to any person participating in the medical care of the patient. Randomization will be performed centrally (with variable block length) and stratified by study center, height of stomata [29, 30] and ,weight at birth (<1000g / ≥1000g), as this is an important prognostic factor for primary endpoint. Randomization will take place after enterostomy creation in order to reduce the amount of missing values due to patient exclusion after surgery (e.g. due to unforeseen need for resection of ileocecal valve). The primary analysis will be performed on the ITT population as this is an open study and parents may have preferences not outspoken before randomization. A per protocol analysis will be conducted as a sensitivity analysis. Consistency between the findings in the ITT population and the per protocol population will be examined as it is an important pre-requisite for a successful interpretation of the study. Drop-Outs are not expected because all patients will constantly undergo neonatal intensive care and will therefore not be lost to follow-up. If parents withdraw their infant from study participation they will be asked to allow data collection at a final analysis in order to avoid that information would be wasted. Nonetheless, if missing values should occur (e.g due to death, or parents’ refusal of data collection) observations will be censored at the last timepoint with known enteral feeding status. Since this censoring may be informative, missing values for time to full feeds will be replaced by the worst observation in each group in a sensitivity analysis in order to check how censoring may have influenced the results. If any death should occur before the respective patient reaches full enteral feeds a sensitivity analysis will be performed on all surviving patients.
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