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Targeted Fortification of Donor Breast Milk in Preterm Infants

This study is looking at ways to improve the growth of premature babies. Researchers are comparing two ways of adding extra nutrients to breast milk for infants born at 30 weeks or less and weighing 1500 grams or less. One group will receive breast milk fortified with Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid, and potentially additional Similac Liquid Protein Fortifier, Nestle Microlipid, or Medica Nutrition SolCarb if needed. The other group will receive breast milk with "targeted fortification" using Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid, meaning the amount of fortifier is adjusted based on the milk's actual nutritional content. The goal is to see if targeted fortification leads to better weight, length, and head circumference in these babies. The study plans to enroll 50 infants, but its current status is unclear.

Study design
This is a randomized controlled trial comparing two different methods of fortifying breast milk. It plans to enroll 50 premature infants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants' weight, length, and head circumference will be measured for up to 11 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04294368

Targeted Fortification of Donor Breast Milk in Preterm Infants

Recruiting
NAAges 1–21InterventionalPrevention
Columbia University
~50 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated LiquidSimilac Liquid Protein FortifierNestle MicrolipidMedica Nutrition SolCarbSimilac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification)Similac Liquid Protein Fortifier (Targeted Fortification)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in weight
Measured over Up to 11 weeks
+2 more outcomes measured

Conditions

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

Explore related trials

Failure to ThrivePreterm Birth

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Marianne Garland, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Marianne Garland, MD
[email protected]
212 305 0952
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Change in weightUp to 11 weeks

    Weight change in g/kg/day, z-score value, and change in z-score from week-to-week

  • Change in lengthUp to 11 weeks

    Length change in cm/kg/day, z-score value, and change in z-score from week-to-week

  • Head circumferenceUp to 11 weeks

    Head circumference change in cm/kg/day, z-score value, and change in z-score from week-to-week