A Randomized Multicenter Open-label Controlled Trial to Show That Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds (MUCous FIstula REfeeding ("MUC-FIRE") Trial)

What this Trial Is About

This research aims to evaluate whether mucous fistula refeeding (MFR) between the creation and closure of an enterostomy can shorten the time for infants to reach full enteral feeding after enterostomy closure. The study focuses on infants with enterostomies, which disrupt normal stool flow and nutrient absorption, often requiring parenteral nutrition with its associated risks. The trial addresses the lack of high-quality evidence supporting MFR despite retrospective reports suggesting benefits like faster weight gain and fewer complications. Participants are randomly assigned to one of two groups: one receiving perioperative mucous fistula refeeding, which involves transferring the infant's own stool back into the unused bowel segment, and the other receiving standard care without refeeding. The study monitors the effects of MFR from the time of enterostomy creation until its closure, focusing on postoperative recovery. The trial is open-label and conducted across multiple centers. Throughout participation, infants will undergo daily assessments from week 1 to week 12, including measuring the time to full enteral feeds, bowel movements, weight gain, laboratory tests indicating liver function and other parameters, adverse events, and nutritional support needs. Follow-up visits occur at 3, 6, and 12 months to continue monitoring growth and health status. The main outcome is the time taken to achieve full enteral feeding, with additional measures assessing overall thriving and postoperative care quality.

Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)