NCT06072976

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 0 Days – 55 Years
• Healthy volunteers: Not accepted

Summary

This study explores the use of an exclusive human milk diet versus standard feeding practices to compare the influence on feeding outcomes and the gut bacteria in infants with intestinal differences.

Conditions

• Gastrointestinal Complication
• Intestinal Obstruction
• Gastroschisis
• Hirschsprung Disease
• Omphalocele
• Midgut Volvulus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Standard of Care	Standard of care arm: Mothers will consent to providing DHM (if qualifies per hospital policy) or formula if MOM is not available. Infants are only eligible to receive donor milk only if 1) MOM is not available 2) if infant initiates feeds before day 3 of age. The donor milk feed would be stopped on day 5 of age.
DIETARY_SUPPLEMENT	Exclusive Human Milk	Mothers will consent to providing DHM if MOM is not available. If the infant reaches 100 ml/kg/day of feeds (one feed advancement prior to full feeds) and MOM remains unavailable, they will transition to formula in preparation for discharge. Infants cannot be discharged on donor milk.

Timeline

• Start date: 2023-06-09
• Primary completion: 2025-06-09
• Completion: 2025-06-09
• First posted: 2023-10-10
• Last updated: 2023-10-10

Locations

1 site across 1 country: United States