Actively Recruiting
Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
Led by Nantes University Hospital · Updated on 2026-04-03
1206
Participants Needed
5
Research Sites
160 weeks
Total Duration
On this page
Sponsors
N
Nantes University Hospital
Lead Sponsor
A
Angers University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The leading cause of birth defects, Congenital Heart Defects (CHD) affect 12 million people worldwide and 41,000 newborns/year in Europe. It's a major cause of life-long morbidity and mortality, and a crucial public health issue. More than 50% of childs born with critical CHD will develop Neurodevelopmental Disorders (NDs), requiring specific care and impairing quality of life. NDs corresponds to early and lasting disturbances in cognitive, affective and behavioral development, linked to abnormalities in brain development. They are heterogeneous, affecting language, learning, motor skills, intellectual efficiency, social cognition, attention, memory and executive functions, and are associated with psychosocial difficulties (adaptive behavior, social interactions). This hidden handicap is the main long-term sequels of CHD, even before cardiovascular sequels, in individuals who often underwent multiple heart operations in early childhood. NDs concern not only complex CHD, but also simple CHD repaired in childhood and considered cured. The origin of TND associated with CHD is largely unknown. To date, few genetic or environmental causes have been clearly identified, but recent work has suggested that a common origin may link cardiac malformation and neurodevelopmental abnormality. The CATAMARAN - Pediatrics project is designed to detect potential neurodevelopmental delays associated with CHD as early as age 3, and to identify individual susceptibility factors involved in the occurrence of NDs in CHD children.
CONDITIONS
Official Title
Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child aged 3 to 11 years with critical congenital heart defect operated on during the first three months of life
- Parents and child covered by social security or a similar scheme
- Parents and child have a good understanding of the French language
- Free, informed, and written consent given by both parents for themselves and the child
- Free, informed, and written consent given by child aged 6 and over
- Both biological parents
You will not qualify if you...
- Genetic anomaly or malformative syndrome linked to neurodevelopmental abnormalities identified before inclusion
- Neurodevelopmental assessment cannot be performed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Chu Brest
Brest, Brittany Region, France, 29200
Actively Recruiting
2
CHU Rennes
Rennes, Brittany Region, France, 35000
Actively Recruiting
3
CHU Nantes
Nantes, Loire-Atlantique, France, 44000
Actively Recruiting
4
CHU Angers
Angers, Maine-et-Loire, France, 49000
Actively Recruiting
5
CHU Tours
Tours, Val de Loire, France, 37000
Actively Recruiting
Research Team
A
Alban Baruteau
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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