Targeted Fortification of Donor Breast Milk in Preterm Infants

Recruiting now · Not applicable

Conditions studied: Prematurity; Extreme, Failure to Thrive in Newborn, Growth Retardation, Growth Failure, Infant Nutrition Disorders

In brief

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.

Key facts

Study ID

NCT04294368

Run by

Columbia University

People needed

50

Starts

2020-03-09

Expected to finish

2027-03-01

Last updated by the study team

2026-04-07

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Premature infants born </= 30 weeks gestational age
• Birth Weight </= 1500 grams

You may not qualify if…

• 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

Where it is running

• Columbia University Medical Center/ New York - Presbyterian — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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