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Heart-Brain link: new study tracks hidden disabilities in babies born with heart defects

NCT ID NCT06690151

Knowledge-focused Sponsor: Nantes University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 2 times

Summary

This study follows 450 babies born with serious heart defects to find early signs of developmental delays by 6 months of age. Researchers want to understand why over half of these children face learning, thinking, or behavior challenges later in life. The goal is to identify risk factors early so that families can get the right support sooner.

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 450 people

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

Started

Feb 2025

Expected to finish

Aug 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

The study population will focus on the inclusion of 150 fetuses with a prenatally diagnosed critical congenital heart defect (CHD), at high risk of developing developmental delays, and their two parents.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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.

The inclusion criteria are as follows: * Fetus with a congenital heart defect (CHD) detected prenatally (prenatal diagnosis of the heart defect) * Fetus with a critical CHD defined as requiring cardiac surgery during the first three months of the infant's life * Parents affiliated with or beneficiaries of a social security or equivalent system * Parents' good understanding of the French language * Voluntary, informed, and written consent from both parents for themselves and the unborn child Criteria for parents\*: \- Biological parents \*The inclusion of the father in the project does not limit the participation of the child (patient) in the study. \*The father will be encouraged to participate in the project by providing a blood sample to create a trio (mother/father/infant) for future genetic analyses. However, if the father is unavailable or does not consent to the collection and storage of samples for analysis (as part of the CATAMARAN study or future research projects related to biobanking), the child can still be included in the study. Exclusion Criteria: * Medical termination of pregnancy considered * Genetic anomaly or malformative syndrome identified prior to inclusion

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Conditions

The condition(s) this trial relates to.

congenital heart disease neurodevelopmental disorder

As listed by the trial registrant

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

Heart disease congenital Neurodevelopmental disorder

How to take part

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

  1. The places running it

    8 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

  • AP-HM

    RECRUITING

    Marseille, France

  • AP-HP Necker

    NOT_YET_RECRUITING

    Paris, France

  • APHP - Antoine Béclère

    RECRUITING

    Clamart, 92140, France

  • CHRU Tours

    RECRUITING

    Tours, France

  • CHU de Bordeaux

    RECRUITING

    Bordeaux, France

  • CHU de Toulouse

    NOT_YET_RECRUITING

    Toulouse, 31000, France

  • Hôpital Marie Lannelongue

    RECRUITING

    Le Plessis-Robinson, 92350, France

  • Nantes University Hospital

    RECRUITING

    Nantes, Loire Atlantique, 44093, France

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