Targeted Fortification of Donor Breast Milk in Preterm Infants

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-21
SponsorColumbia University

About this trial

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.

Eligibility criteria

Qualifiers

Premature infants born </= 30 weeks gestational age

Birth Weight </= 1500 grams

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • 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)
  • Similac Liquid Protein Fortifier (Targeted Fortification)
  • Nestle Microlipid (Targeted Fortification)
  • Medica Nutrition SolCarb (Targeted Fortification)
  • Analysis with Miris (AB) Human Milk Analyzer

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators