Status:
RECRUITING
Targeted Fortification of Donor Breast Milk in Preterm Infants
Lead Sponsor:
Columbia University
Conditions:
Prematurity; Extreme
Failure to Thrive in Newborn
Eligibility:
All Genders
1-21 years
Phase:
NA
Brief Summary
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 dete...
Detailed Description
Breast milk is the best food for premature infants due to its ability to protect infants from necrotizing enterocolitis (NEC) and late onset sepsis. When a premature infant's mother's own milk supply ...
Eligibility Criteria
Inclusion
- Premature infants born \</= 30 weeks gestational age
- Birth Weight \</= 1500 grams
Exclusion
- Parents do no consent to donor milk
- Confounders for poor growth such as congenital heart disease, GI diagnoses such as gastroschisis and omphalocele, and or major congenital anomalies
- Grade III or IV intraventricular hemorrhage diagnoses prior to randomization
- Small for gestational age (\<3% on Fenton Growth Curve)
- Failure to initiate fortified feeds prior to 3 weeks of life
- Diagnosis of necrotizing entercolitis prior to randomization
- Diagnosis of early onset sepsis confirmed with positive culture
Key Trial Info
Start Date :
March 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04294368
Start Date
March 9 2020
End Date
March 1 2026
Last Update
May 14 2025
Active Locations (1)
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1
Columbia University Medical Center/ New York - Presbyterian
New York, New York, United States, 10032