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Could a few drops of milk help preterm Babies' brains?

NCT ID NCT06230848

Knowledge-focused 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested whether giving very small amounts of human milk by mouth to preterm infants (born 22-34 weeks) starting at 3 days old is practical and acceptable. 14 babies received up to 1 mL of milk after each care session until they could feed on their own. The study measured how often the milk was given, parent satisfaction, and early signs of development. The goal is to see if this simple method might reduce stress and improve outcomes for premature babies.

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 this approach works, it could lead to a simple, low-cost way to support brain development and reduce stress in premature babies.
What could go wrong
This is a very small pilot study with only 14 babies, so results may not apply to all preterm infants. The main goal is just to see if the method is practical, not to prove it works.

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

14 people

The number who actually took part.

Started

Oct 2023

Finished

Oct 2024

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

0 years to 1 year

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 between 22 to 34 weeks gestational age and receiving mother's own milk and/or donor milk. Exclusion Criteria: * receiving only formula, oral cavity defects, gastrointestinal defects, chromosomal abnormalities, severe cardiac defects that require surgery, or intraventricular hemorrhage grade III or IV

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As listed by the trial registrant

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

Infant development Stress

Contacts and locations

Locations

  • Loyola University Chicago

    Maywood, Illinois, 60153, United States

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