Characterization and Support for Neurodevelopmental Disorders Associated with Congenital Heart Defects
Launched by NANTES UNIVERSITY HOSPITAL · May 29, 2024
Trial Information
Current as of February 19, 2025
Recruiting
Keywords
ClinConnect Summary
The clinical trial titled "Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects" is focused on understanding the connection between congenital heart defects (CHD) and neurodevelopmental disorders (NDs). Congenital heart defects are heart problems present at birth that can affect a child’s overall development. Many children born with serious heart defects may also experience difficulties in learning, language, and social skills as they grow. This study aims to identify early signs of these developmental delays in children as young as three years old, as well as to explore factors that may increase the risk of these disorders in children with CHD.
To participate in the trial, children must have undergone heart surgery for critical congenital heart defects within the first three months of life. Both parents and the child should be able to understand French, and they must provide written consent to take part in the study. Importantly, children with known genetic conditions that cause neurodevelopmental issues are not eligible. Participants will undergo assessments to monitor their development, allowing researchers to gather valuable information to help improve care for children with CHD and associated challenges.
Gender
ALL
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
About Nantes University Hospital
Nantes University Hospital, a leading academic medical institution in France, is dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific exploration with patient care, fostering collaborations among multidisciplinary teams of healthcare professionals and researchers. With a strong emphasis on ethical standards and patient safety, Nantes University Hospital aims to contribute to the development of effective therapies and interventions that enhance patient outcomes and overall public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rennes, Bretagne, France
Nantes, Loire Atlantique, France
Brest, Bretagne, France
Angers, Maine Et Loire, France
Tours, Val De Loire, France
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0