Understanding neurodevelopmental disorders in children with congenital heart defects
Official title: CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
Run by Nantes University Hospital · NCT06442592 · Data updated 2026-11-12
This study is trying to see how heart surgery in young children with serious heart defects affects their brain development and behavior as they grow up.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 11 Years |
| Sex | All |
| Enrollment | 1206 (estimated) |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 5 sites (Brest, Brittany Region and 4 other locations) |
| Status | Recruiting |
| Started | July 8, 2024 |
| Main results expected | July 8, 2027 |
| Study ends | August 8, 2027 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT06442592 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3 to 11 who have had heart surgery for critical congenital heart defects within the first three months of life.
✕Probably not a fit
Patients with pre-existing genetic anomalies or malformative syndromes associated with neurodevelopmental abnormalities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on children aged 3 to 11 who have undergone heart surgery for critical congenital heart defects (CHD) within their first three months of life. It aims to assess the neurodevelopmental outcomes of these children, as over 50% are at risk of developing neurodevelopmental disorders (NDs). The study involves blood sampling and various assessments to evaluate neurodevelopment and parental stress, providing insights into the cognitive and behavioral challenges faced by these children. By understanding the link between CHD and NDs, the study seeks to improve care strategies for affected families.
Why it matters
Potential benefit: If successful, this study could lead to better support and interventions for children with congenital heart defects and their neurodevelopmental challenges.
How similar studies have gone: Other studies have indicated a significant association between congenital heart defects and neurodevelopmental disorders, suggesting that this approach is grounded in existing research.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Chu Brest
Brest, Brittany Region, France Recruiting -
CHU Rennes
Rennes, Brittany Region, France Recruiting -
CHU Nantes
Nantes, Loire-Atlantique, France Recruiting -
CHU Angers
Angers, Maine-et-Loire, France Recruiting -
CHU Tours
Tours, Val de Loire, France Recruiting
Study contacts
- Study coordinator: Alban Baruteau
- Email: albanelouen.baruteau@chu-nantes.fr
- Phone: 02 40 08 77 42
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This project will try to see how often and why babies with prenatally diagnosed critical congenital heart defects develop early neurodevelopmental problems by following them from before birth through infancy.
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Creating a DNA bank for congenital heart disease in southeastern France
This study is creating a DNA bank for people with congenital heart defects in southeastern France to help understand the genetic causes of these conditions better.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.