Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects

Not Applicable

Recruiting

• Conditions: Neurodevelopmental Disorder; Congenital Heart Defects
• Interventions: Other: Blood sampling; Diagnostic Test: Assessment of neurodevelopment (Nantes); Diagnostic Test: Assessment of neurodevelopment (CA); Other: Assessment of the parental stress

• Registration Number: NCT06442592
• Lead Sponsor: Nantes University Hospital

Brief 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 impair...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-05-29
• Study First Posted: 2024-06-04
• Status Verified: 2024-07
• Study Start: 2024-07-08
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-07-01
• Study Completion: 2025-08-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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

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Exclusion Criteria

• Genetic anomaly or malformative syndrome associated with neurodevelopmental abnormalities, identified prior to inclusion
• Neurodevelopmental assessment not practicable

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CATAMARAN - Pediatrics - Associated centers (excluding Nantes)	Assessment of the parental stress	The study population will consist of 200 children aged 3 to 11 and their two parents.
CATAMARAN - Pediatrics - Nantes	Blood sampling	The study population will consist of 200 children aged 3 to 11 and their two parents.
CATAMARAN - Pediatrics - Nantes	Assessment of neurodevelopment (Nantes)	The study population will consist of 200 children aged 3 to 11 and their two parents.
CATAMARAN - Pediatrics - Nantes	Assessment of the parental stress	The study population will consist of 200 children aged 3 to 11 and their two parents.
CATAMARAN - Pediatrics - Associated centers (excluding Nantes)	Blood sampling	The study population will consist of 200 children aged 3 to 11 and their two parents.
CATAMARAN - Pediatrics - Associated centers (excluding Nantes)	Assessment of neurodevelopment (CA)	The study population will consist of 200 children aged 3 to 11 and their two parents.

Primary Outcome Measures

Name	Time	Method
Assessment of the prevalence of neurodevelopmental disorders in children aged 3-11 years with critical congenital heart defects.	14 days

Secondary Outcome Measures

Name	Time	Method
Identify rare genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.	One day	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.
Identify frequent genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.	One day	The presence of frequent 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.
Assessment of the prevalence of neurodevelopmental disorders in children with critical congenital heart defects in each age subgroup (3, 5, 7, and 11 years).	up to 14 days
Evaluate and describe the neurodevelopmental domains affected in the pediatric population of Nantes.	up to 14 days	Functional diagnosis of different types of NDD defined by at least one score deficient in relation to the test norm (-1.5 standard deviation or 90 percentile) in each age subgroup.
Assessment of the quality of life and psychopathological aspects of the child as well as parental stress.	up to 14 days	Proportion of children with impaired quality of life, psychopathological difficulties and proportion of adults with parental stress, compared with the test norm (-1.5 standard deviation or 90 percentile).
Assessment of diagnostic accuracy (of NDD) provided by an innovative multidisciplinary approach.	up to 14 days	Comparison of TND frequency in Nantes versus associated centers and description of differences between centers
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).	up to 14 days

Trial Locations

Locations (5)

CHU Angers; 🇫🇷 Angers, Maine-et-Loire, France

CHU Tours; 🇫🇷 Tours, Val De Loire, France

CHU Rennes; 🇫🇷 Rennes, Bretagne, France

CHU Nantes; 🇫🇷 Nantes, Loire-Atlantique, France

Chu Brest; 🇫🇷 Brest, Bretagne, France