Study Comparing Exclusive Human Milk Versus Standard Feeding on Gut Health and Feeding Progress in Newborns with Intestinal Birth Defects

What this Trial Is About

Researchers are evaluating how feeding methods affect feeding outcomes and gut bacteria in infants with congenital gastrointestinal conditions such as gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, and Hirschsprung disease. The study compares an exclusive human milk diet with standard feeding practices to understand their impact on these infants. This research is sponsored by Seattle Childrens Hospital and focuses on infants from birth up to 55 years old, although primarily neonates are involved given the conditions studied. The trial has two main feeding approaches. In the exclusive human milk group, mothers provide donor human milk DHM if their own milk MOM is unavailable. If the infant reaches 100 mlkgday of feeds and MOM remains unavailable, they switch to formula before discharge infants cannot be discharged on donor milk. In the standard care group, mothers consent to providing DHM or formula if MOM is not available, but donor milk is only given if feeds start before day 3 of age and stopped by day 5. If donor milk is not suitable, formula is used. The feeding plan follows hospital policies and considers the infants readiness for feeds. Participants are closely monitored from birth up to 120 days or until discharge. Researchers measure the time to reach full feeds, rates of central line infections, the proportion of mothers own milk at discharge, and analyze gut and mothers milk microbiomes for diversity and abundance. They also assess antigen-specific immunoglobulin levels over the study period. This comprehensive monitoring helps understand how feeding type influences health and gut bacteria in these fragile infants.

The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies