Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects

Congenital Heart Defects Clinical Trial

— CATAMARAN Ped  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06442592
• Other study ID #: RC23_0548
• Secondary ID: 2024-A00428-39
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: May 2024
• Source: Nantes University Hospital
• Contact: Alban Baruteau
• Phone: 02 40 08 77 42
• Email: albanelouen.baruteau[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: August 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 11 Years

Eligibility

Inclusion Criteria:

• Child 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

Related Conditions & MeSH terms

• Congenital Heart Defects
• Heart Defects, Congenital
• Neurodevelopmental Disorder
• Neurodevelopmental Disorders

Intervention

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
The children will be seen by a neuropsychologist, who will then determine whether or not they have neurodevelopmental disorders.

Locations

Country	Name	City	State
France	CHU Angers	Angers	Maine-et-Loire
France	Chu Brest	Brest	Bretagne
France	CHU Nantes	Nantes	Loire-Atlantique
France	CHU Rennes	Rennes	Bretagne
France	CHU Tours	Tours	Val De Loire

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	University of Angers - Pays de la Loire psychology laboratory

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the prevalence of neurodevelopmental disorders in children aged 3-11 years with critical congenital heart defects.		14 days
Secondary	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.	14 days