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Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
Sponsor: Nantes University Hospital
Summary
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.
Official title: CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
Key Details
Gender
All
Age Range
3 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
1206
Start Date
2024-07-08
Completion Date
2027-08-08
Last Updated
2026-04-03
Healthy Volunteers
No
Interventions
Blood sampling
An EDTA blood sample will be taken from the children and their two parents. Sample volume will be 2 x 3mL.
Assessment of neurodevelopment (CA)
The children will be seen by a neuropsychologist, who will then determine whether or not they have neurodevelopmental disorders.
Assessment of neurodevelopment (Nantes)
The children will be seen by a multidisciplinary team (including a neuropsychologist), who will then determine whether or not they have neurodevelopmental disorders.
Assessment of the parental stress
Parents' parental stress will be assessed using the Parental Stress Index (PSI) questionnaire.
Locations (5)
Chu Brest
Brest, Brittany Region, France
CHU Rennes
Rennes, Brittany Region, France
CHU Nantes
Nantes, Loire-Atlantique, France
CHU Angers
Angers, Maine-et-Loire, France
CHU Tours
Tours, Val de Loire, France