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Can a home coaching program boost preterm Babies' brains?

NCT ID NCT04685356

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a home-based program called IBAIP for very preterm babies (born before 33 weeks). The program coaches parents to support their baby's self-regulation and development from hospital discharge to 6 months corrected age. Researchers will measure the babies' cognitive, language, and motor skills at age 2. The goal is to see if this early, family-centered approach improves long-term brain development.

What this could mean

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

Active substance
Infant Behaviour Assessment and Intervention Program (IBAIP) - a home-based family-centered intervention
What this could lead to
If it works, this could point toward a simple, home-based way to improve brain development in very preterm infants.
What could go wrong
This is a relatively small, early-stage study. The program may not show clear benefits, and results may not apply to all preterm babies.

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

About 240 people

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

Started

Nov 2022

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.

Ages

25 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.

Inclusion Criteria : * Preterm infants born (including multiple pregnancies) at a gestational age between 25 weeks +0 days and 32 weeks + 6days. * Written informed consent of at least one of the parents / legal guardian or 2 parents / legal guardians depending on the family context * Normal neurological examination between 36 and 41 weeks of corrected age Exclusion Criteria: * Intraventricular hemorrhage (III or IV), periventricular leukomalacia * Brain MRI abnormalities performed after 36 weeks of corrected age * Life-threatening pathology * Severe congenital abnomality * Severe maternal pathology (physical and / or mental) * Parents whose native language is not French * Participation in another interventional study on the management of post-hospital neurodevelopment disorders

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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 birth

How to take part

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

  1. The places running it

    7 sites. 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

  • CHRU Strasbourg

    RECRUITING

    Strasbourg, France

  • CHU Angers

    RECRUITING

    Angers, France

  • CHU Besançon

    RECRUITING

    Besançon, France

  • CHU Brest

    RECRUITING

    Brest, 29200, France

  • CHU Caen

    RECRUITING

    Caen, 14033, France

  • CHU Grenoble

    RECRUITING

    Grenoble, France

  • CHU Nantes

    WITHDRAWN

    Nantes, 44000, France

  • CHU Rennes

    WITHDRAWN

    Rennes, France

  • CHU Tours

    RECRUITING

    Tours, 37000, France

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