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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 55
Healthy Volunteers: f
View:

• Infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease.

Locations
United States
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Contact Information
Primary
Leonel Arellano
leonel.arellano@seattlechildrens.org
915-443-4390
Time Frame
Start Date: 2023-06-09
Estimated Completion Date: 2025-06-09
Participants
Target number of participants: 116
Treatments
Experimental: 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.
Experimental: Standard of care
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. After day five of age, the infant will receive formula if MOM is not available. This is congruent with the current donor milk policy (see Policy #12785). It is highly unlikely given these infants would receive any donor milk because these infants require surgery and often are waiting return of bowel function . The median age of initiation of feeds is 12 days of age for infants with gastroschisis (PMID: 33647253) which exceeds the days of what the hospital policy says for eligibility which is initiates feed before day 3 of age. If the infant does not qualify for any donor milk and MOM is not available, the infant will receive formula
Sponsors
Leads: Seattle Children's Hospital

This content was sourced from clinicaltrials.gov