Blood sampling
OtherAn EDTA blood sample will be taken from the children and their two parents. Sample volume will be 2 x 3mL.
NCT Number: NCT06442592
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.
Interested in participating?
Request Info3 year–11 year
All sexes
Interventional
Not applicable
Chu Brest, Brest, Brittany Region, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An EDTA blood sample will be taken from the children and their two parents. Sample volume will be 2 x 3mL.
The children will be seen by a neuropsychologist, who will then determine whether or not they have neurodevelopmental disorders.
The children will be seen by a multidisciplinary team (including a neuropsychologist), who will then determine whether or not they have neurodevelopmental disorders.
Parents' parental stress will be assessed using the Parental Stress Index (PSI) questionnaire.
Time frame: 14 days
Time frame: One day
The presence of rare genetic variants associated with neurodevelopmental disorders will be determined by a 30X whole genome sequencing approach based on the association study of congenital heart defects with neurodevelopmental disorders versus congenital heart defects without neurodevelopmental disorders.
Time frame: One day
The presence of frequent genetic variants associated with neurodevelopmental disorders will be determined by a 30X whole genome sequencing approach based on the association study of congenital heart defects with neurodevelopmental disorders versus congenital heart defects without neurodevelopmental disorders.
Time frame: up to 14 days
Time frame: up to 14 days
Functional diagnosis of different types of NDD defined by at least one score deficient in relation to the test norm (-1.5 standard deviation or 90 percentile) in each age subgroup.
Time frame: up to 14 days
Proportion of children with impaired quality of life, psychopathological difficulties and proportion of adults with parental stress, compared with the test norm (-1.5 standard deviation or 90 percentile).
Time frame: up to 14 days
Comparison of TND frequency in Nantes versus associated centers and description of differences between centers
Time frame: up to 14 days
Contact information is provided by the study sponsor or research team.
Nantes University Hospital
Other
CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
Acronym: CATAMARAN Ped
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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