Home › Premature Birth › NCT04294368
Targeted Fortification of Donor Breast Milk in Preterm Infants
Who can join
1 Day – 21 Days · All sexes
Full eligibility criteria
Inclusion Criteria: * Premature infants born \</= 30 weeks gestational age * Birth Weight \</= 1500 grams Exclusion Criteria: * 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
About the study
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.
What is being tested
- Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (dietary supplement)
- Similac Liquid Protein Fortifier (dietary supplement)
- Nestle Microlipid (dietary supplement)
- Medica Nutrition SolCarb (dietary supplement)
- Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification) (dietary supplement)
- Similac Liquid Protein Fortifier (Targeted Fortification) (dietary supplement)
Sponsor: Columbia University · Participants: 50 · Started: Mar 9, 2020
Contact the study team
- Marianne Garland, MD · Phone: 212 305 0952
Official record on ClinicalTrials.gov — NCT04294368
Locations in the U.S.
| New York | Columbia University Medical Center/ New York - Presbyterian, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.