Use of Breast Milk and Other Feeding Practices Following Gastrointestinal Surgery in Infants.
Sanskriti Varma, Edward L Bartlett, Lucy Nam...
https://pubmed.ncbi.nlm.nih.gov/30119100Actively Recruiting
Phase Not Applicable
Age: 0Days - 55Years
All Genders
ID06072976
The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies
Led by Seattle Children's Hospital · Updated on 2026-04-30
116
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
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 Children's 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 ml/kg/day 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 mother's own milk at discharge, and analyze gut and mother's 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.
CONDITIONS
Brief Title
The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies
Who Can Participate
Age: 0Days - 55Years
All Genders
Eligibility Criteria
You may qualify if you...
- Infants diagnosed with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, or Hirschsprung disease
You will not qualify if you...
- Infant has already started feeding
- Infants younger than 34 weeks gestation
- Parents with contraindications to providing milk (such as cocaine, fentanyl, or methamphetamine use; oxycodone, suboxone, and marijuana use are allowed)
- Presence of complicated gastroschisis
- Diagnosis of short gut syndrome
- Additional congenital anomalies affecting milk tolerance, like cyanotic congenital heart disease (kidney disease is allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - From birth until up to 120 days or until discharge
Participants receive assigned feeding based on group: either exclusive human milk with donor milk as needed or standard of care involving donor milk and formula depending on availability and hospital policy.
Trial Site Locations
Total: 1 location
1
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
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Research Team
L
Leonel Arellano
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Supplementation of Mother's Own Milk with Donor Milk in Infants with Gastroschisis or Intestinal Atresia: A Retrospective Study.
Rebecca Hoban, Supriya Khatri, Aloka Patel...
https://pubmed.ncbi.nlm.nih.gov/32102333Growth, Body Composition, and Neurodevelopmental Outcomes at 2 Years Among Preterm Infants Fed an Exclusive Human Milk Diet in the Neonatal Intensive Care Unit: A Pilot Study.
Erynn M Bergner, Roman Shypailo, Chonnikant Visuthranukul...
https://pubmed.ncbi.nlm.nih.gov/32298596Beyond Necrotizing Enterocolitis: Other Clinical Advantages of an Exclusive Human Milk Diet.
Amy B Hair, David J Rechtman, Martin L Lee...
https://pubmed.ncbi.nlm.nih.gov/29877722Low rate of necrotizing enterocolitis in extremely low birth weight infants using a hospital-based preterm milk bank.
Swati Murthy, Pamela R Parker, Steven J Gross
https://pubmed.ncbi.nlm.nih.gov/30291318Growth outcomes of small for gestational age preterm infants before and after implementation of an exclusive human milk-based diet.
Lindsay Fleig, Joseph Hagan, Martin L Lee...
https://pubmed.ncbi.nlm.nih.gov/34012050Dilemmas in feeding infants with intestinal failure: a neonatologist's perspective.
Amy B Hair, Misty Good
https://pubmed.ncbi.nlm.nih.gov/36127395Use of breast milk in infants with uncomplicated gastroschisis: A retrospective cohort study.
Emily C Hodgson, Michael H Livingston, Tessa Robinson...
https://pubmed.ncbi.nlm.nih.gov/35058060Cost and Use of Pasteurized Donor Human Milk at a Children's Hospital.
Diane L Spatz, Abbey C Robinson, Elizabeth B Froh
https://pubmed.ncbi.nlm.nih.gov/29221672Source of human milk (mother or donor) is more important than fortifier type (human or bovine) in shaping the preterm infant microbiome.
Shreyas V Kumbhare, William-Diehl Jones, Sharla Fast...
https://pubmed.ncbi.nlm.nih.gov/36029771