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Heart-Brain link: major study seeks hidden causes of learning delays in children with heart defects

NCT ID NCT06442592

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study will follow over 1,200 children aged 3 to 11 who were born with critical heart defects and had heart surgery in their first three months. Researchers want to find out how many of these children develop learning, attention, or behavioral problems, and why. They will use blood tests and brain assessments to look for genetic and other factors that might link heart and brain development. The goal is to catch these issues early and improve support for affected children and families.

What this could mean

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

What this could lead to
If successful, this could lead to earlier detection and better support for children with heart defects who are at risk for learning or behavioral challenges.
What could go wrong
This is an observational study, not a treatment trial. It will not directly change how children are treated, and results may take years to influence care.

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 1,206 people

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

Started

Jul 2024

Expected to finish

Aug 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

3 to 11 years

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: * Child (aged 3 to 11) with critical MCC operated on for heart surgery during the first three months of life * Parents and child affiliated with or benefiting from a social security or similar scheme * Parents' and child's good understanding of the French language * Free, informed and written consent of both parents for themselves and for the child * Free, informed and written consent of the child aged 6 and over * Biological parents Exclusion Criteria: * Genetic anomaly or malformative syndrome associated with neurodevelopmental abnormalities, identified prior to inclusion * Neurodevelopmental assessment not practicable

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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.

Congenital heart defects 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

    5 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

  • CHU Angers

    RECRUITING

    Angers, Maine-et-Loire, 49000, France

  • CHU Nantes

    RECRUITING

    Nantes, Loire-Atlantique, 44000, France

  • CHU Rennes

    RECRUITING

    Rennes, Brittany Region, 35000, France

  • CHU Tours

    RECRUITING

    Tours, Val de Loire, 37000, France

  • Chu Brest

    RECRUITING

    Brest, Brittany Region, 29200, France

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