Characterization and Support of Neurodevelopmental Disorders Associated with Congenital Cardiac MalfoRmations - Neonatal
- Conditions
- Heart Disease CongenitalNeurodevelopmental Disorder
- Registration Number
- NCT06690151
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
Congenital heart defects (CHD), as the leading cause of birth defects, affect 12 million people globally and approximately 41,000 newborns each year in Europe. CHD presents a significant public health concern due to its association with high morbidity and mortality rates across the lifespan. Over 50% of infants born with critical CHD will develop neurodevelopmental disorders (NDD), requiring specialized care and impacting their quality of life. NDDs, involving early and persistent disruptions in cognitive, emotional, and behavioral development due to abnormal brain development, are highly variable. They may impact language, learning, motor skills, intellectual efficiency, social cognition, attention, memory, and executive functions, often accompanied by psychosocial difficulties. These hidden disabilities constitute the primary long-term sequelae of CHD, surpassing even cardiovascular complications in impact, and affect children who often undergo multiple cardiac surgeries during early childhood. NDDs are associated not only with complex CHDs but also with simpler CHDs that are repaired in early childhood and considered 'cured.'
The origin of CHD-associated NDDs remains largely unknown. While few genetic or environmental causes have been identified, recent research suggests a possible common origin linking heart malformations and neurodevelopmental abnormalities. The CATAMARAN neonatal cohort project aims to detect developmental delays associated with CHD as early as six months of age and to identify both individual susceptibility factors and acquired vulnerabilities contributing to the development of NDDs in infants with CHD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 450
Not provided
- Medical termination of pregnancy considered
- Genetic anomaly or malformative syndrome identified prior to inclusion
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the prevalence of developmental delays in infants with a critical congenital heart defect (CHD) at 6 months of age. 6 months
- Secondary Outcome Measures
Name Time Method Evaluate the prevalence of developmental delay in infants with congenital heart defects (CHD) based on the type of heart defect. 6 months Assess the presence of developmental delay in infants with CHD based on the complexity of cardiac surgery. 6 months Evaluate and describe affected developmental domains. 6 months Identify rare genetic variants associated with developmental delays in CHD patients through genome-wide analysis. 6 months Identify common genetic variants associated with developmental delays in CHD patients through genome-wide analysis. 6 months Characterize placental anatomopathological anomalies in CHD and their correlation with developmental delay at 6 months. 6 months Determine maternal dietary habits during the third trimester, their correlation with placental anomalies, and developmental delay at 6 months. 6 months Characterize maternal behavioral exposures (e.g., tobacco, alcohol, drugs) and obstetric complications (e.g., hypertension, preeclampsia, gestational diabetes) during pregnancy, and their correlation with placental anomalies and developmental delay 6 months Characterize antenatal determinants of developmental delay through multi-omics analysis (metabolomics, lipidomics, transcriptomics, and epigenetics) of maternal blood, placental function, and fetal blood, and their correlation with developmental delay 6 months Characterize neonatal microbiota and its association with developmental delay at 6 months. 6 months Identify perioperative determinants of developmental delay in CHD. 6 months Identify optimal perfusion pressure targets during and after neonatal cardiac surgery under cardiopulmonary bypass in three participating centers using continuous analysis of invasive blood pressure and cerebral oxygen saturation up to 3 months For CHU Nantes patients only: identify fetal neuronal biomarkers at birth, track their evolution before and after cardiac surgery in CHD infants, and establish associations with developmental delay at 6 months. 6 months Evaluate parental post-traumatic stress at 1) antenatal inclusion, 2) perioperative period, and 3) 6 months post-surgery, and its correlation with developmental delay at 6 months. 6 months
Trial Locations
- Locations (1)
Nantes University Hospital
🇫🇷Nantes, Loire Atlantique, France