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Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects

Key facts

Who runs it
Nantes University Hospital
Where
France5 sites in 1 countryChoose a country to see its 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?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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