Study of Neurodevelopmental Disorders in Children Aged 3 to 11 With Critical Congenital Heart Defects and Their Families

What this Trial Is About

Congenital Heart Defects CHD are the leading cause of birth defects affecting millions worldwide, including 41,000 newborns annually in Europe. Over half of children born with critical CHD develop Neurodevelopmental Disorders NDs, which impact cognitive, behavioral, and social development. These disorders often appear early, before cardiovascular complications, and affect various functions such as language, learning, memory, and social interactions. The CATAMARAN - Pediatrics project aims to detect neurodevelopmental delays as early as age 3 and identify factors that increase the risk of NDs in children with CHD. The study involves 201 children aged 3 to 11 who had critical CHD and underwent heart surgery within the first three months of life, along with their two parents. Children will undergo neurodevelopmental assessments by neuropsychologists and multidisciplinary teams to identify any disorders. Blood samples will be collected from the children and parents to analyze genetic factors. Parents will complete questionnaires assessing parental stress. The study is non-randomized and observational in nature. Participants will be evaluated over a period of up to 14 days during which neurodevelopmental functioning, quality of life, and parental stress will be assessed. Researchers will measure the prevalence and nature of neurodevelopmental disorders in different age groups and evaluate the accuracy of the multidisciplinary diagnostic approach. Genetic analyses will identify rare and common variants linked to neurodevelopmental disorders. The study continues until August 2027 and aims to improve understanding and support for children with CHD and associated neurodevelopmental challenges.

Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects