Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Protein-Packed breast milk could help tiny preemies grow stronger

NCT ID NCT04325308

Disease control Sponsor: University of Alabama at Birmingham 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This study tests whether adding extra protein to breast milk during the first two weeks of life helps extremely preterm infants (born at 28 weeks or earlier) gain more lean body mass and develop a healthier gut microbiome. About 150 babies will be randomly assigned to receive either protein-enriched human milk or standard human milk. The goal is to see if the extra protein improves growth and gut bacteria diversity by the time they reach their original due date.

What this could mean

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

Active substance
human-based protein supplement added to human milk
What this could lead to
If it works, this could improve growth and gut health in extremely preterm infants, reducing long-term health problems.
What could go wrong
This is an early-stage trial with only 150 infants, so results may not apply to all preterm babies. Adding protein may also cause digestive issues or other side effects.

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

150 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Sep 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 4 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 ≤ 28 weeks of gestation * Postnatal age \< 96 hours Exclusion Criteria: * Congenital malformations * Chromosomal anomalies * Terminal illness needing to limit or withhold support

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast milk expression are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Breast Milk Expression Failure to Thrive infectious disease Premature Birth

As listed by the trial registrant

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

Breast milk expression Feeding disorder neonatal Growth failure Microbial colonization Prematurity; extreme

Contacts and locations

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

More trials for these conditions

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