Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
Key facts
- Who runs it
- Nantes University Hospital
- Where
- Angers, Brest, Nantes, Rennes, and Tours, FranceSee the 5 sites
- Trial code
- Status
- Recruiting
- People taking part
- 1,206 people, planned
- Started
- 8 Jul 2024
- Expected to end
- 8 Aug 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- Blood sampling
- Assessment of neurodevelopment (CA)
- Assessment of neurodevelopment (Nantes)
- Assessment of the parental stress
- Record updated
- 3 April 2026
Who can take part
- Age
- 3 years to 11 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- Genetic anomaly or malformative syndrome associated with neurodevelopmental abnormalities, identified prior to inclusion
- Neurodevelopmental assessment not practicable
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 11 years old?
Where in France
- CHU AngersAngers, FranceContact: Anne-Sophie Lety (principal investigator)Taking people
- Chu BrestBrest, FranceContact: Guillaume DEVERRIERETaking people
- CHU NantesNantes, FranceContact: Alban BaruteauTaking people
- CHU RennesRennes, FranceContact: Clémence Le Seven (principal investigator)Taking people
- CHU ToursTours, FranceContact: Bruno Lefort (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- CATAMARAN - Pediatrics - Interdisciplinary programme - Nantes OnlyOther group
The study population will consist of 201 children aged 3 to 11 and their two parents.
Treatment: Blood sampling, Assessment of neurodevelopment (Nantes), and Assessment of the parental stress
- CATAMARAN - Pediatrics - Unique neuropsychological assessment Associated centers (including Nantes)Other group
The study population will consist of 201 children aged 3 to 11 and their two parents.
Treatment: Blood sampling, Assessment of neurodevelopment (CA), and Assessment of the parental stress
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
- Fit questions
- Built from NCT06442592, who can take part
- Record updated
- 3 April 2026