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Could donor milk give late preterm babies a healthier start than formula?

NCT ID NCT03220282

Disease control Sponsor: University of California, San Francisco 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares banked donor breast milk to preterm formula for late preterm infants (born at 34–36 weeks) who need extra nutrition while their mothers' milk supply increases. Researchers will track the babies' weight gain and analyze their gut bacteria to see which supplement supports healthier growth and microbial balance. The goal is to determine whether donor milk should be offered more widely to this group.

What this could mean

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

Active substance
donor breast milk
What this could lead to
If donor milk helps late preterm babies grow and develop healthy gut bacteria, it could become a standard supplement for these infants.
What could go wrong
This is a small, early-stage study with only 48 babies, so results may not apply to all preterm infants. Donor milk is pasteurized and may lack some nutrients found in fresh mother's milk.

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 48 people

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

Started

Oct 2017

Expected to finish

Jan 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 hour to 96 hours

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: * Late preterm newborns \>=34 weeks and \<37 weeks gestation * Breastfeeding * Clinical team plans to start supplementation Exclusion Criteria: * Mothers are producing copious breast milk * Birth weight \<2100gm * Any maternal or infant contraindication to breastfeeding

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Conditions

The condition(s) this trial relates to.

Breast Feeding infectious disease Premature Birth

As listed by the trial registrant

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

Breast milk substitute intolerance Breastfeeding Growth delay Microbial colonization Preterm infant

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • University of California, San Francisco Medical Center

    San Francisco, California, 94122, United States

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