NCT06442592

Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects

CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,206 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Defects
• Neurodevelopmental Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-08
• Primary completion: 2027-07-08
• Completion: 2027-08-08
• First posted: 2024-06-04
• Last updated: 2026-04-03

Locations

5 sites across 1 country: France