Feeding Source and Gut Health in Infants with Intestinal Conditions
This study is looking at how different feeding methods affect the gut (digestive system) and how quickly infants with certain intestinal problems can start eating normally. It compares two approaches: an "Exclusive Human Milk" diet, where infants receive human milk (from their mother or a donor), versus "Standard of Care," which might include formula if mother's milk isn't available. The study is for infants from birth up to 55 years old who have conditions like gastroschisis (intestines outside the body), omphalocele (intestines covered by a sac outside the body), or Hirschsprung disease (a nerve problem in the large intestine). The main goal is to see which feeding method helps infants reach full feeds faster. The study plans to enroll 116 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study comparing two feeding approaches in 116 planned participants. It is not specified if it is randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from birth to 120 days or until discharge to measure the time to full feed.
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The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Katie Strobel, MD · PRINCIPAL_INVESTIGATOR · Seattle Children's Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Time to full feedFrom birth to 120 days or until discharge
: In infants with congenital gastrointestinal pathologies (gastroschisis, giant omphalocele, atresia, midgut volvulus, Hirschsprung disease, CGP), to determine if use of an exclusive human milk diet will decrease the number of days to full feeding volume (120 ml/kg/day) (29 subjects per power calculation) compared to human milk/formula