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Could a few drops of milk boost preemie brain and feeding?

NCT ID NCT07216664

Symptom relief Sponsor: Loyola 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a simple intervention called M-MILK, where very preterm infants (born before 32 weeks) receive small amounts of human milk by mouth starting at 3 days old. Researchers want to see if this helps babies handle stress, develop their brains, and learn to feed better compared to standard care. The trial will include 125 infants and measure stress hormones, feeding skills, and brain development.

What this could mean

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

Active substance
human milk (mother's own or donor)
What this could lead to
If it works, this simple approach could improve stress regulation, brain development, and feeding skills in very preterm infants.
What could go wrong
This is a small, early-stage trial with 125 babies, so results may not apply to all preterm infants. The intervention is low-risk but may not show clear benefits.

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 125 people

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

Started

Nov 2025

Expected to finish

May 2031

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

23 to 32 weeks

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: * Born at ≤ 32 weeks gestational age. * Receiving mother's own milk and/or donor human milk at the time of screening. Exclusion Criteria: * Receiving only formula. * Gastrointestinal defects, i.e., cleft lip or cleft palate. * Congenital cardiac defects requiring surgery. * Necrotizing enterocolitis. * Chromosomal abnormalities.

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Conditions

The condition(s) this trial relates to.

Infant, Premature, Diseases

As listed by the trial registrant

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

Infant, premature, diseases

How to take part

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

  1. The places running it

    2 sites. 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

  • Loyola University Chicago

    RECRUITING

    Maywood, Illinois, 60153, United States

  • Loyola University Medical Center

    RECRUITING

    Maywood, Illinois, 60153, United States

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