Clinical trial NCT06442592: Characterization and Support for Neurodevelopmental Disorders Associated with Congenital Heart Defects
Official title: CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated with Congenital Heart Defects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Defects
Neurodevelopmental Disorder
Keywords: Congenital Heart Defects
Neurodevelopmental Disorder
Genetics
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: University of Angers - Pays de la Loire psychology laboratory
First posted: 2024-06-04
Enrollment: 1206
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.


Eligibility 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

Primary outcomes:
measure: Assessment of the prevalence of neurodevelopmental disorders in children aged 3-11 years with critical congenital heart defects.
timeFrame: 14 days
Secondary outcomes:
measure: Identify rare genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.
timeFrame: One day
measure: Identify frequent genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.
timeFrame: One day
measure: Assessment of the prevalence of neurodevelopmental disorders in children with critical congenital heart defects in each age subgroup (3-5, 6-8, and 9-11 years).
timeFrame: up to 14 days
measure: Evaluate and describe the neurodevelopmental domains affected in the pediatric population of Nantes.
timeFrame: up to 14 days
measure: Assessment of the quality of life and psychopathological aspects of the child as well as parental stress.
timeFrame: up to 14 days
measure: Assessment of diagnostic accuracy (of NDD) provided by an innovative multidisciplinary approach.
timeFrame: up to 14 days
measure: Describe the different types of neurodevelopmental disorders (number and nature of neurodevelopmental domains affected) in each age subgroup (intelligence, oral language, motor skills, school learning, executive functions, social interactions).
timeFrame: up to 14 days
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
state: Bretagne
city: Rennes
country: France
facility: CHU Rennes
state: Bretagne
city: Nantes
country: France
facility: CHU Nantes
state: Loire-Atlantique
city: Angers
country: France
facility: CHU Angers
state: Maine-et-Loire
city: Tours
country: France
facility: CHU Tours
state: Val de Loire
Study officials:
References: