Actively Recruiting
Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects in Children Aged 3 to 11
Led by Nantes University Hospital · Updated on 2026-04-03
1206
Participants Needed
5
Research Sites
4 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
Congenital Heart Defects (CHD) are the leading cause of birth defects affecting millions worldwide, including 41,000 newborns annually in Europe. Over half of children born with critical CHD develop Neurodevelopmental Disorders (NDs), which impact cognitive, behavioral, and social development. These disorders often appear early, before cardiovascular complications, and affect various functions such as language, learning, memory, and social interactions. The CATAMARAN - Pediatrics project aims to detect neurodevelopmental delays as early as age 3 and identify factors that increase the risk of NDs in children with CHD. The study involves 201 children aged 3 to 11 who had critical CHD and underwent heart surgery within the first three months of life, along with their two parents. Children will undergo neurodevelopmental assessments by neuropsychologists and multidisciplinary teams to identify any disorders. Blood samples will be collected from the children and parents to analyze genetic factors. Parents will complete questionnaires assessing parental stress. The study is non-randomized and observational in nature. Participants will be evaluated over a period of up to 14 days during which neurodevelopmental functioning, quality of life, and parental stress will be assessed. Researchers will measure the prevalence and nature of neurodevelopmental disorders in different age groups and evaluate the accuracy of the multidisciplinary diagnostic approach. Genetic analyses will identify rare and common variants linked to neurodevelopmental disorders. The study continues until August 2027 and aims to improve understanding and support for children with CHD and associated neurodevelopmental challenges.
CONDITIONS
Brief 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
- Biological parents and child affiliated with or benefiting from social security or similar scheme
- Both parents and child have good understanding of the French language
- Free, informed, and written consent of both parents for themselves and the child
- Free, informed, and written consent of the child aged 6 years and over
- Biological parents willing to participate
You will not qualify if you...
- Known genetic anomaly or malformative syndrome associated with neurodevelopmental abnormalities identified before inclusion
- Neurodevelopmental assessment not practicable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants undergo assessments including blood sampling, neurodevelopment evaluations, and parental stress questionnaires to characterize neurodevelopmental disorders associated with congenital heart defects.
1 to 2 visits depending on assessment type
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
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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