Characterization and Support for Neurodevelopmental Disorders Associated with Congenital Heart Defects (CATAMARAN Ped)

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Congenital Heart Defects; Neurodevelopmental Disorder

Treatments: Diagnostic Test: Assessment of neurodevelopment (CA); Other: Blood sampling; Other: Assessment of the parental stress; Diagnostic Test: Assessment of neurodevelopment (Nantes)

Study type: Interventional

Funder types: Other

Identifiers

NCT06442592

2024-A00428-39 (Other Identifier)

RC23_0548

Details and patient eligibility

About

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.

Enrollment: 1,206 estimated patients

Sex: All

Ages: 3 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,206 participants in 2 patient groups

CATAMARAN - Pediatrics - Nantes

Other group

Description:

The study population will consist of 201 children aged 3 to 11 and their two parents.

Treatment:

Diagnostic Test: Assessment of neurodevelopment (Nantes)

Other: Assessment of the parental stress

Other: Blood sampling

CATAMARAN - Pediatrics - Associated centers (excluding Nantes)

Other group

Description:

The study population will consist of 201 children aged 3 to 11 and their two parents.

Treatment:

Other: Assessment of the parental stress

Other: Blood sampling

Diagnostic Test: Assessment of neurodevelopment (CA)