Cure My Disease

Don't miss your cure!

 Log in / Sign up

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

NCT ID NCT01534481

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

483 people

The number who actually took part.

Started

Aug 2012

Finished

Nov 2021

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 21 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Gestational age less than 29 weeks. * Admitted to the NICU at less than or equal to 72 hours of life * Survived at least 12 hours Exclusion Criteria: * Chromosomal anomalies * Cyanotic congenital heart disease * Diagnosed intrauterine infection * Other congenital disorders known to impair neurodevelopment * NEC or IP prior to seeking consent * Decision documented to limit intensive care therapies * Congenital disorders that may affect feeding Feeding Group Eligibility: * Sole Diet Group: Infants will be eligible for the sole diet feeding protocol if the mother declines to provide breast milk for the baby. * Supplemental Diet (minimal maternal milk) Group: Infants whose mothers initially choose to provide breast milk and begin pumping will be re-screened for eligibility at least weekly until the infant is 21 days old. If the mother stops expressing milk at any point prior to the infant's 21st day of life, her infant will be eligible for randomization. In addition, those whose mothers are providing less than 20% of the infant's dietary needs (averaged over past 5 days) when the infant reaches 21 days of age will be eligible for randomization at this point. No infant will be randomized after reaching 21 days.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Infant, extremely low birth weight are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.