Breast Milk Feeding for Neonatal Gastrointestinal Complications
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
Is feeding donor human milk safe for newborns?
How is the treatment of exclusive human milk unique for neonatal gastrointestinal complications?
Exclusive human milk feeding is unique because it provides essential nutrients and immune protection that can reduce the risk of gastrointestinal complications like necrotizing enterocolitis in newborns, especially those born prematurely. Unlike formula, human milk contains specific proteins and fatty acids that enhance digestion and absorption, and it can be fortified to meet the additional nutritional needs of low-birthweight infants.26789
What data supports the effectiveness of the treatment Exclusive Human Milk, Exclusive Breast Milk, Donor Human Milk, Human Milk Feeding, Standard of Care, Standard Treatment, Conventional Care, Usual Care for neonatal gastrointestinal complications?
Who Is on the Research Team?
Katie Strobel, MD
Principal Investigator
Seattle Children's Hospital
Are You a Good Fit for This Trial?
This trial is for infants with specific intestinal conditions like gastroschisis, omphalocele, and Hirschsprung's disease. It's not open to those who've started feeding, are under 34 weeks gestation, or have complications that prevent milk tolerance.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants receive either an exclusive human milk diet or standard feeding practices to assess feeding outcomes and gut microbiome changes
Follow-up
Participants are monitored for safety and effectiveness after treatment, including central line infection rates and gut microbiome analysis
What Are the Treatments Tested in This Trial?
Interventions
- Exclusive Human Milk
- Standard of Care
Exclusive Human Milk is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seattle Children's Hospital
Lead Sponsor