CompletedNot Applicable

Neurodevelopmental Disorders in Children With Congenital Heart Disease

France233 participantsStarted 2017-12-06

Plain-language summary

Children with congenital heart disease are at risk for neurodevelopmental disorders, these disorders impacting their quality of life and their integration into society. The aim of this study is to detect neurodevelopmental disorders in children (aged from 6 to 66 months) with congenital heart disease in Nord-Pas-De-Calais (France) and to evaluate the frequency and risk factors of these neurodevelopmental disorders for a better follow-up. This study will help implementing a specific program for the evaluation and management of neurodevelopmental disorders in children suffering from congenital heart disease in Nord-Pas-De-Calais and more globally, in the region Hauts-De-France.

Who can participate

Age range

6 Months – 66 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged 6 to 66 months at the time of study * living in region "Nord-Pas-De-Calais" * with " significant" congenital heart disease (= complex congenital heart diseases operated or not, simple or moderate congenital heart disease who had cardiac surgery) * Followed by the Pediatric Cardiology Department of Lille University Hospital, or patients having a cardiopediatric follow-up outside Lille University Hospital but having been taken in charge at the University Hospital of Lille for any reason (cardiac or not) Exclusion Criteria: Children : * lost to sight * Deceased * with congenital heart disease, living in Nord-Pas-de-Calais but never having been taken in charge at Lille University Hospital * with mild or moderate congenital heart disease not having undergone surgery or having only undergone cardiac catheterization * with cardiac surgery not performed in the Centers of Jacques CARTIER and Marie LANNNELONGUE

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of children classified "at risk" for neuro-developmental disorders by the Age & Stage Questionnaire Third Edition in French (ASQ3) score

Timeframe: Baseline: one session

Trial details

NCT IDNCT03360370

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-06-06

View on ClinicalTrials.gov More Congenital Heart Disease trials