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Nurse-Led screening may spot developmental issues in kids with heart defects

NCT ID NCT06431269

Knowledge-focused Sponsor: University Hospital, Montpellier 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 explores whether an advanced practice nurse can effectively screen for neurodevelopmental disorders (like learning or behavior problems) in children aged 1 to 5 who have congenital heart disease. Researchers will compare the nurse's screening results with a full assessment by a neuropsychologist. The goal is to see if this simpler, nurse-led approach can reliably identify children who need further evaluation, potentially making early detection more accessible.

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 270 people

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

Started

May 2024

Expected to finish

Jun 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

1 year to 5 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: * Congenital heart disease with stable status defined by last operation \>3 months, no cardiac decompensation in the last 3 months, no planned surgery within 6 months after the inclusion * Cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life, * Patient aged 1 to 5 years. * No previous medical diagnosis of NDD * Parental or legal guardian's consent. * Social security affiliation (for France only) Exclusion Criteria: * Patients with a genetic or poly-malformative syndrome with known neurological impairment. * Neurodevelopmental disorder already known/treated * Neurodevelopmental status evaluation within the last 6 months.

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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 disease in children Neurodevelopmental disorders

How to take part

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

  1. The places running it

    3 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 Bordeaux Haut-Lévêque

    NOT_YET_RECRUITING

    Pessac, 33600, France

  • Institut Marin Saint-Pierre

    NOT_YET_RECRUITING

    Palavas-les-Flots, 34250, France

  • University Hospitial of Montpellier

    RECRUITING

    Montpellier, 34295, France

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