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Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal
Sponsor: Nantes University Hospital
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.
Official title: CATAMARAN - Neonatal Cohort : Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
450
Start Date
2025-02-28
Completion Date
2027-08-28
Last Updated
2026-03-20
Healthy Volunteers
No
Interventions
Neurodevelopmental assessment (Bayley-IV)
Assessment of developmental delays through administration of the Bayley-4 test by a neuropsychologist
Biological sampling
The samples to be collected at delivery will include: * A 4 ml maternal blood sample in an EDTA tube for lipidomic and metabolomic analyses at delivery * A 6 ml maternal blood sample in an EDTA tube (2 tubes of 3 ml) for genetic analysis * A 4 ml venous cord blood sample in an EDTA tube for transcriptomic and epigenetic analysis; and a 2 ml EDTA tube for metabolomic/lipidomic analysis * Samples from fresh placenta for transcriptomic, epigenetic, metabolomic, and lipidomic analyses * A meconium sample collected as soon as possible after birth in a dry tube for microbiome analysis During hospitalization for the cardiac surgery: * Genome analysis samples will be collected from the father and the infant. These samples will be taken in two EDTA tubes of 3 ml each. * Perioperative neurobiomarker samples will be collected (one EDTA tube of 500 μL preoperatively and postoperatively on Day 1 and 2). At 1 month, a stool sample will be collected from the infants for microbiome analysis.
ELFE dietary questionnaire
Questionnaire on diet and lifestyle during pregnancy (only for the mother)
Post-Traumatic Stress Questionnaire IES-R (Impact of Event Scale - Revised)
The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events.
Data collection for the study (Cardiovascular, developemental, fetal, pregnancy, MRI)
* Cardiovascular follow-up data collection * Developmental follow-up data collection * Collection of postoperative brain MRI data, scheduled between Day 5 post-surgery and the end of the hospital stay * Collection of data on pregnancy exposure, obstetric events, and delivery data. * Collection of fetal ultrasound data (T2 and T3). * Collection of fetal echocardiography data (T2 and T3).
Locations (8)
Nantes University Hospital
Nantes, Loire Atlantique, France
CHU de Bordeaux
Bordeaux, France
APHP - Antoine Béclère
Clamart, France
Hôpital Marie Lannelongue
Le Plessis-Robinson, France
AP-HM
Marseille, France
AP-HP Necker
Paris, France
CHU de Toulouse
Toulouse, France
CHRU Tours
Tours, France