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Early boost: fortifying breast milk sooner may help preterm babies grow better

NCT ID NCT05525585

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether adding extra nutrients (fortification) to breast milk earlier (between days 4-7) helps very preterm infants (born 29-33 weeks) grow better and develop a healthier gut compared to waiting until days 10-14. Eighty infants will be randomly assigned to one of two fortification schedules. The main goal is to measure fat-free body mass and gut bacteria diversity.

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 fortifier (added to breast milk)
What this could lead to
If early fortification works, it could improve growth and gut health in very preterm infants, reducing feeding problems.
What could go wrong
This is a small, early-stage trial with only 80 infants, so results may not apply to all preterm babies. The intervention is a dietary supplement, not a drug, so benefits may be modest.

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

80 people

The number who actually took part.

Started

Nov 2022

Expected to finish

May 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 29 to 33 weeks of gestation * Birth weight \< 1800 g * Postnatal age \< 96 hours Exclusion Criteria: * Small for gestational age (\<5th percentile) * Major congenital/chromosomal anomalies * Terminal illness needing withhold or limit support

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Enteral feeding intolerance Light-for-dates Prematurity

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.