Targeted Fortification of Donor Breast Milk in Preterm Infants

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

Targeted Fortification of Donor Breast Milk in Preterm Infants

Targeted Fortification of Donor Breast Milk in Preterm Infants

Condition
Prematurity; Extreme
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Medical Center/ New York - Presbyterian, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

1 Day to 21 Days

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Columbia University,

Marianne Garland, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

2025-04