Actively Recruiting
Targeted Fortification of Donor Breast Milk in Preterm Infants
Led by Columbia University · Updated on 2026-04-07
50
Participants Needed
1
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.
CONDITIONS
Official Title
Targeted Fortification of Donor Breast Milk in Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premature infants born </= 30 weeks gestational age
- Birth weight </= 1500 grams
You will not qualify if you...
- Parents do not consent to donor milk
- Presence of confounding conditions for poor growth such as congenital heart disease, gastroschisis, omphalocele, or major congenital anomalies
- Grade III or IV intraventricular hemorrhage diagnosed before randomization
- Small for gestational age (less than 3% on Fenton Growth Curve)
- Failure to start fortified feeds before 3 weeks of age
- Diagnosis of necrotizing enterocolitis before randomization
- Diagnosis of early onset sepsis confirmed with positive culture
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Medical Center/ New York - Presbyterian
New York, New York, United States, 10032
Actively Recruiting
Research Team
M
Marianne Garland, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here