Understanding neurodevelopmental disorders in children with congenital heart defects
CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1206 (estimated) |
| Ages | 3 Years to 11 Years |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 5 sites (Brest, Brittany Region and 4 other locations) |
| Trial ID | NCT06442592 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with pre-existing genetic anomalies or malformative syndromes associated with neurodevelopmental abnormalities may not benefit from this study.
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 performed: Other studies have indicated a significant association between congenital heart defects and neurodevelopmental disorders, suggesting that this approach is grounded in existing research.
Eligibility criteria
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 this trial is running
Brest, Brittany Region and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.