Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sampling, Assessment of neurodevelopment (CA), Assessment of neurodevelopment (Nantes), Assessment of the parental stress.
- Who it may be relevant to
- Registry conditions: Congenital Heart Defects, Neurodevelopmental Disorder. Basic parameters: 3 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
Overview
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.
Interventions
- Other Blood sampling
An EDTA blood sample will be taken from the children and their two parents. Sample volume will be 2 x 3mL. - Diagnostic test Assessment of neurodevelopment (CA)
The children will be seen by a neuropsychologist, who will then determine whether or not they have neurodevelopmental disorders. - Diagnostic test 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. - Other Assessment of the parental stress
Parents' parental stress will be assessed using the Parental Stress Index (PSI) questionnaire.
Primary outcome measures
- Assessment of the prevalence of neurodevelopmental disorders in children aged 3-11 years with critical congenital heart defects. [Time frame: 14 days]
Secondary outcome measures (7)
- Identify rare genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects. [Time frame: One day]
- Identify frequent genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects. [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). [Time frame: up to 14 days]
- Assessment of the quality of life and psychopathological aspects of the child as well as parental stress. [Time frame: up to 14 days]
- Assessment of diagnostic accuracy (of NDD) provided by an innovative multidisciplinary approach. [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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
France · 5 centers
- Chu Brest — Brest
- CHU Rennes — Rennes
- CHU Nantes — Nantes
- CHU Angers — Angers
- CHU Tours — Tours
Identifiers
NCT: NCT06442592 · RC23_0548 · 2024-A00428-39