Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal
Recruiting now
Conditions studied: Heart Disease Congenital, Neurodevelopmental Disorder
In brief
Congenital heart defects (CHD), as the leading cause of birth defects, affect 12 million people globally and approximately 41,000 newborns each year in Europe. CHD presents a significant public health concern due to its association with high morbidity and mortality rates across the lifespan. Over 50% of infants born with critical CHD will develop neurodevelopmental disorders (NDD), requiring specialized care and impacting their quality of life. NDDs, involving early and persistent disruptions in cognitive, emotional, and behavioral development due to abnormal brain development, are highly variable. They may impact language, learning, motor skills, intellectual efficiency, social cognition, attention, memory, and executive functions, often accompanied by psychosocial difficulties. These hidden disabilities constitute the primary long-term sequelae of CHD, surpassing even cardiovascular complications in impact, and affect children who often undergo multiple cardiac surgeries during early childhood. NDDs are associated not only with complex CHDs but also with simpler CHDs that are repaired in early childhood and considered 'cured.' The origin of CHD-associated NDDs remains largely unknown. While few genetic or environmental causes have been identified, recent research suggests a possible common origin linking heart malformations and neurodevelopmental abnormalities. The CATAMARAN neonatal cohort project aims to detect developmental delays associated with CHD as early as six months of age and to identify both individual susceptibility factors and acquired vulnerabilities contributing to the development of NDDs in infants with CHD.
Key facts
- Study ID
- NCT06690151
- Run by
- Nantes University Hospital
- People needed
- 450
- Starts
- 2025-02-28
- Expected to finish
- 2028-08-28
- Last updated by the study team
- 2026-07-01
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Medical termination of pregnancy considered
- Genetic anomaly or malformative syndrome identified prior to inclusion
Where it is running
- CHRU Tours — Tours, France (enrolling)
- CHU de Bordeaux — Bordeaux, France (enrolling)
- APHP - Antoine Béclère — Clamart, France (enrolling)
- Hôpital Marie Lannelongue — Le Plessis-Robinson, France (enrolling)
- AP-HM — Marseille, France (enrolling)
- Nantes University Hospital — Nantes, Loire Atlantique, France (enrolling)
- CHU de Toulouse — Toulouse, France
- AP-HP Necker — Paris, France
Full record on ClinicalTrials.gov
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