Breast milk from donors vs. formula: which builds a better brain for tiny babies?

NCT ID NCT01534481

Completed Disease control Sponsor: NICHD Neonatal Research Network Source: ClinicalTrials.gov ↗

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study tests whether extremely low birth weight infants (born before 29 weeks) who receive donor human milk during their hospital stay have better brain development than those given preterm formula. Infants whose mothers cannot or choose not to breastfeed are randomly assigned to one of the two diets. Their cognitive skills are measured at 22 to 26 months of age using the Bayley Scales of Infant Development.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: donor human milk or preterm formula
What this could lead to: If donor milk improves brain development, it could become the standard diet for extremely low birth weight infants whose mothers cannot provide breast milk.
What could go wrong: This is a single trial with 483 infants, and results may not apply to all hospitals or populations. Donor milk is costly and may not show a clear advantage over formula.

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Conditions

The condition(s) this trial relates to.

fetal growth restriction Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

INFANT, EXTREMELY LOW BIRTH WEIGHT INFANT, NEWBORN INFANT, SMALL FOR GESTATIONAL AGE

Contacts and locations

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Locations

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States
Children's Mercy Hospital

Kansas City, Missouri, 64108, United States
Duke University

Durham, North Carolina, 27710, United States
Emory University

Atlanta, Georgia, 30303, United States
Indiana University

Indianapolis, Indiana, 46202, United States
RTI International

Durham, North Carolina, 27705, United States
Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States
Stanford University

Palo Alto, California, 94304, United States
University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States
University of Iowa

Iowa City, Iowa, 52242, United States
University of New Mexico

Albuquerque, New Mexico, 87131, United States
University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
University of Rochester

Rochester, New York, 14642, United States
University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States
University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States
Wayne State University

Detroit, Michigan, 48201, United States

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