NCT06442592 Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
| NCT ID | NCT06442592 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Congenital Heart Defects |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,206 participants |
| Start Date | 2024-07-08 |
| Primary Completion | 2027-07-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,206 participants in total. It began in 2024-07-08 with a primary completion date of 2027-07-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Genetic anomaly or malformative syndrome associated with neurodevelopmental abnormalities, identified prior to inclusion * Neurodevelopmental assessment not practicable
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06442592 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 11 Years, studying Congenital Heart Defects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06442592 currently recruiting?
Yes, NCT06442592 is actively recruiting participants. Contact the research team at albanelouen.baruteau@chu-nantes.fr for enrollment information.
Where is the NCT06442592 trial being conducted?
This trial is being conducted at Brest, France, Rennes, France, Nantes, France, Angers, France and 1 additional location.
Who is sponsoring the NCT06442592 clinical trial?
NCT06442592 is sponsored by Nantes University Hospital. The trial plans to enroll 1,206 participants.