An interventional study of Blood sampling and Assessment of neurodevelopment (CA) in Congenital Heart Defects and Neurodevelopmental Disorder, sponsored by Nantes University Hospital. Recruiting at 5 sites in France. Open to participants aged 3 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Screening
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.
1,007 studies on the registry are indexed under Heart Defects, Congenital; 257 are open to participants now.
This study's planned enrollment of 1,206 is above the median of 60 across 524 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The study population will consist of 201 children aged 3 to 11 and their two parents.
Other: Blood sampling · Diagnostic Test: Assessment of neurodevelopment (Nantes) · Other: Assessment of the parental stress
The study population will consist of 201 children aged 3 to 11 and their two parents.
Other: Blood sampling · Diagnostic Test: Assessment of neurodevelopment (CA) · Other: Assessment of the parental stress
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.
Assessment of the prevalence of neurodevelopmental disorders in children aged 3-11 years with critical congenital heart defects.
Time frame: 14 days
Identify rare genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.
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
Identify frequent genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.
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: One day
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).
Time frame: up to 14 days
Evaluate and describe the neurodevelopmental domains affected in the pediatric population of Nantes (Multidisciplinary assessment).
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
Assessment of the quality of life and psychopathological aspects of the child as well as parental stress.
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
Assessment of diagnostic accuracy (of NDD) provided by an innovative multidisciplinary approach.
Comparison of TND frequency in Nantes versus associated centers and description of differences between centers
Time frame: up to 14 days
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).
Time frame: up to 14 days
Plan to share: Undecided
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Nantes University Hospital