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Targeted Fortification of Donor Breast Milk in Preterm Infants

RecruitingNAAges 1 Day - 21 DaysAllColumbia University
NCT04294368 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid
  • Similac Liquid Protein Fortifier
  • Nestle Microlipid
  • Medica Nutrition SolCarb
  • Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification)
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Where

1 site
Columbia University Medical Center/ New York - Presbyterian
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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