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Can early feeding shape a premature Baby's brain and body?

NCT ID NCT06226051

Knowledge-focused Sponsor: University of Wisconsin, Madison 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study looks at how the nutrition premature babies receive in the neonatal intensive care unit (NICU) affects their body composition and future development. Researchers will measure body fat and muscle using a special device called PEAPOD and track growth and neurodevelopmental outcomes over 36 months. The goal is to understand if early nutrition influences healthy weight gain and brain development in this vulnerable population.

What this could mean

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

Active substance
PEAPOD Infant Body Composition measuring device
What this could lead to
If successful, this could help tailor nutrition for premature infants to improve their growth and brain development.
What could go wrong
This is an observational study, so it cannot prove cause and effect. Results may not apply to all premature infants, and the follow-up period is limited.

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

Sep 2024

Expected to finish

Jan 2028

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

120 neonates born inpatient at Meriter Hospital, Inc. ≤ 32 weeks 6 days (32w6d) GA (possible gestational age range from 22w0d-32w6d)

Ages

22 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.

Neonate Inclusion Criteria: * Born inpatient at Meriter Hospital, Inc. at or above 22 gestational weeks. Upper limit is 32 weeks 6 days GA (possible gestational age range from 22w0d-32w6d) Neonate Exclusion Criteria: * Known genetic condition that impacts neurodevelopmental outcomes or brain structure development * Multiple major congenital anomalies * Per the investigator's opinion, the subject will likely require transfer to American Family Children's Hospital (AFCH) before 36 weeks PMA * Any neonate who enrolls in the study and then unexpectedly requires transfer to AFCH before 36 weeks PMA will be excluded from the study if they are unable to obtain at least one body composition measurement before transfer. Body composition data points can only be collected at Meriter Hospital due to the location of PEAPOD Birthing Parent Inclusion Criteria: * Birthing parent must speak English or Spanish due to consent documents * Able to understand and willing to sign a written informed consent document * Primary caregiver of a neonate who is eligible to participate in the study * Agrees to enroll neonate into the study * Willing to comply with all study procedures and be available for the duration of the study * Age 15 or older Birthing Parent Exclusion Criteria: * Subject is unable to provide informed consent, including subjects in foster care and subjects within state custody * Does not plan to maintain custody of the child after birth, such as in instances of adoption or surrogacy

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Conditions

The condition(s) this trial relates to.

fetal growth restriction Premature Birth

As listed by the trial registrant

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

Intrauterine growth restriction Premature Premature birth Premature infant Small for gestational age at delivery

How to take part

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

  1. The places running it

    1 site. 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

  • Meriter Hospital, Inc.

    RECRUITING

    Madison, Wisconsin, 53715, United States

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