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Could a High-Protein diet in the NICU boost preemie brain development?

NCT ID NCT04190875

Knowledge-focused Sponsor: Baylor College of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows up on extremely low birth weight infants (under 1000 grams) who received either a standard or high-protein diet while in the NICU. Researchers want to see if the higher protein diet leads to better growth, body composition, and neurodevelopment at 18-24 months of age. The study is currently suspended.

What this could mean

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

Active substance
high-protein diet (targeted fortification of human milk)
What this could lead to
If successful, this could show that a higher protein diet in the NICU leads to better long-term growth and brain development in extremely premature infants.
What could go wrong
This is a small, suspended follow-up study, so results may not be conclusive. The diet was given in the NICU, and many other factors affect a child's development.

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.

Participants

About 120 people

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

Started

Feb 2019

Expected to finish

Feb 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.

Who is studied

Children 18-24 months corrected age, who participated in an earlier study H-38611. These children were either born at Texas Children's Hospital in the first 24 hours of life and admitted to our Neonatal Intensive Care Unit. These infants had a birth weight of less than or equal to 1000 grams and were randomized to receive a standard protein diet (3.5-3.8 grams of protein per kilogram of body weight) or a high protein diet (4.2-4.5 grams of protein per kilogram of body weight). Infants in both groups received recommended clinical guidelines for protein.

Ages

18 to 24 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Children born prematurely, with birth weight of less than or equal to 1000 grams * Born at Texas Children's Hospital or transferred to the Neonatal Intensive Care Unit from another hospital in the first 24 hours of life * Completed a previous study (H-38611) in which the child received targeted protein fortification with donor human milk products Exclusion Criteria: * Infants not previously enrolled in a previous study (H-38611) in the Neonatal Intensive Care Unit at Texas Children's Hospital * Infants enrolled in but did not complete a previous study (H-38611) in the Neonatal Intensive Care Unit at Texas Children's Hospital

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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.

Premature infants

How to take part

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  1. The places running it

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  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

  • Baylor College of Medicine / Texas Children's Hospital

    Houston, Texas, 77030, United States

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