Characterization and Support of Neurodevelopmental Disorders Associated with Congenital Cardiac MalfoRmations - Neonatal

Launched by NANTES UNIVERSITY HOSPITAL · Nov 13, 2024

Keywords

ClinConnect Summary

This clinical trial, called the CATAMARAN project, is focusing on understanding the developmental challenges faced by infants born with congenital heart defects (CHD). These heart defects are the most common type of birth defect and can lead to serious health issues. The study aims to identify any delays in development, such as difficulties with learning, communication, and social skills, in babies with CHD as early as six months old. Researchers hope to find out what factors might make some babies more susceptible to these challenges, as well as any potential connections between heart problems and brain development.

To participate in this trial, families must meet certain criteria. Eligible infants are those diagnosed with a significant heart defect before birth that requires surgery shortly after they are born. Parents should be fluent in French and willing to give informed consent for themselves and their unborn child. Both parents are encouraged to participate, especially the father, who may provide a blood sample for future studies. It’s important to note that if a genetic condition is found or if a pregnancy is ended for medical reasons, the baby won't be included in the study. Overall, this research aims to improve our understanding of how congenital heart defects can impact a child's development and to enhance care for these children and their families.

Gender

ALL

Eligibility criteria

• The inclusion criteria are as follows:
• • Fetus with a congenital heart defect (CHD) detected prenatally (prenatal diagnosis of the heart defect)
• • Fetus with a critical CHD defined as requiring cardiac surgery during the first three months of the infant's life
• • Parents affiliated with or beneficiaries of a social security or equivalent system
• • Parents' good understanding of the French language
• • Voluntary, informed, and written consent from both parents for themselves and the unborn child
• Criteria for parents\*:
• • - Biological parents \*The inclusion of the father in the project does not limit the participation of the child (patient) in the study.
• • \*The father will be encouraged to participate in the project by providing a blood sample to create a trio (mother/father/infant) for future genetic analyses.
• • However, if the father is unavailable or does not consent to the collection and storage of samples for analysis (as part of the CATAMARAN study or future research projects related to biobanking), the child can still be included in the study.
• Exclusion Criteria:
• • Medical termination of pregnancy considered
• • Genetic anomaly or malformative syndrome identified prior to inclusion