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Tailored donor milk may help tiny preemies grow better

NCT ID NCT04294368

Disease control Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether customizing the nutrients in donor breast milk helps preterm babies (born at 30 weeks or earlier, weighing under 3.3 pounds) grow better than standard fortification. Fifty infants will be randomly assigned to receive either standard or targeted fortification. Researchers will track weight, length, and head growth, as well as hospital stay and complications.

What this could mean

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

Active substance
fortified donor breast milk with targeted nutrient adjustment
What this could lead to
If it works, this could improve growth and reduce complications in preterm infants who rely on donor milk.
What could go wrong
This is a small early-stage trial with only 50 infants, so results may not apply broadly. The intervention may not significantly improve growth over standard care.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2020

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

1 day 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: * Premature infants born \</= 30 weeks gestational age * Birth Weight \</= 1500 grams Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Failure to Thrive Infant Nutrition Disorders nutritional disorder Premature Birth

As listed by the trial registrant

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

Failure to thrive in newborn Growth failure Growth retardation Infant nutrition disorders Prematurity; extreme

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University Medical Center/ New York - Presbyterian

    RECRUITING

    New York, New York, 10032, United States

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