Characterization and Support for Neurodevelopmental Disorders Associated with Congenital Heart Defects
NCT ID: NCT06442592
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1206 participants
INTERVENTIONAL
2024-07-08
2025-08-08
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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CATAMARAN - Pediatrics - Nantes
The study population will consist of 201 children aged 3 to 11 and their two parents.
Blood sampling
An EDTA blood sample will be taken from the children and their two parents. Sample volume will be 2 x 3mL.
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.
Assessment of the parental stress
Parents' parental stress will be assessed using the Parental Stress Index (PSI) questionnaire.
CATAMARAN - Pediatrics - Associated centers (excluding Nantes)
The study population will consist of 201 children aged 3 to 11 and their two parents.
Blood sampling
An EDTA blood sample will be taken from the children and their two parents. Sample volume will be 2 x 3mL.
Assessment of neurodevelopment (CA)
The children will be seen by a neuropsychologist, who will then determine whether or not they have neurodevelopmental disorders.
Assessment of the parental stress
Parents' parental stress will be assessed using the Parental Stress Index (PSI) questionnaire.
Interventions
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Blood sampling
An EDTA blood sample will be taken from the children and their two parents. Sample volume will be 2 x 3mL.
Assessment of neurodevelopment (CA)
The children will be seen by a neuropsychologist, who will then determine whether or not they have neurodevelopmental disorders.
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.
Assessment of the parental stress
Parents' parental stress will be assessed using the Parental Stress Index (PSI) questionnaire.
Eligibility Criteria
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Inclusion Criteria
* 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
* Neurodevelopmental assessment not practicable
3 Years
11 Years
ALL
No
Sponsors
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University of Angers - Pays de la Loire psychology laboratory
UNKNOWN
Nantes University Hospital
OTHER
Responsible Party
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Locations
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Chu Brest
Brest, Brittany Region, France
CHU Rennes
Rennes, Brittany Region, France
CHU Nantes
Nantes, Loire-Atlantique, France
CHU Angers
Angers, Maine-et-Loire, France
CHU Tours
Tours, Val de Loire, France
Countries
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Central Contacts
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Facility Contacts
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Guillaume DEVERRIERE
Role: primary
Guillaume DEVERRIERE
Role: backup
Clémence Le Seven
Role: primary
Alban Baruteau
Role: primary
Alban Baruteau
Role: backup
Anne-Sophie Lety
Role: primary
Bruno Lefort
Role: primary
Other Identifiers
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2024-A00428-39
Identifier Type: OTHER
Identifier Source: secondary_id
RC23_0548
Identifier Type: -
Identifier Source: org_study_id