Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
CATAMARAN Ped
CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
2 other identifiers
interventional
1,206
1 country
5
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2024
CompletedFirst Posted
Study publicly available on registry
June 4, 2024
CompletedStudy Start
First participant enrolled
July 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 8, 2026
March 30, 2026
March 1, 2026
2 years
May 29, 2024
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of the prevalence of neurodevelopmental disorders in children aged 3-11 years with critical congenital heart defects.
14 days
Secondary Outcomes (7)
Identify rare genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.
One day
Identify frequent genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.
One day
Assessment of the prevalence of neurodevelopmental disorders in children with critical congenital heart defects in each age subgroup (3-5, 6-8, and 9-11 years).
up to 14 days
Evaluate and describe the neurodevelopmental domains affected in the pediatric population of Nantes.
up to 14 days
Assessment of the quality of life and psychopathological aspects of the child as well as parental stress.
up to 14 days
- +2 more secondary outcomes
Study Arms (2)
CATAMARAN - Pediatrics - Nantes
OTHERThe study population will consist of 201 children aged 3 to 11 and their two parents.
CATAMARAN - Pediatrics - Associated centers (excluding Nantes)
OTHERThe study population will consist of 201 children aged 3 to 11 and their two parents.
Interventions
The children will be seen by a multidisciplinary team (including a neuropsychologist), who will then determine whether or not they have neurodevelopmental disorders.
Parents' parental stress will be assessed using the Parental Stress Index (PSI) questionnaire.
An EDTA blood sample will be taken from the children and their two parents. Sample volume will be 2 x 3mL.
The children will be seen by a neuropsychologist, who will then determine whether or not they have neurodevelopmental disorders.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Neurodevelopmental assessment not practicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Chu Brest
Brest, Brittany Region, 29200, France
CHU Rennes
Rennes, Brittany Region, 35000, France
CHU Nantes
Nantes, Loire-Atlantique, 44000, France
CHU Angers
Angers, Maine-et-Loire, 49000, France
CHU Tours
Tours, Val de Loire, 37000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2024
First Posted
June 4, 2024
Study Start
July 8, 2024
Primary Completion (Estimated)
July 8, 2026
Study Completion (Estimated)
August 8, 2026
Last Updated
March 30, 2026
Record last verified: 2026-03