NCT06690151

Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal

CATAMARAN - Neonatal Cohort : Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Disease Congenital
• Neurodevelopmental Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Neurodevelopmental assessment (Bayley-IV)	Assessment of developmental delays through administration of the Bayley-4 test by a neuropsychologist
OTHER	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.
BEHAVIORAL	ELFE dietary questionnaire	Questionnaire on diet and lifestyle during pregnancy (only for the mother)
BEHAVIORAL	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.
OTHER	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).

Timeline

• Start date: 2025-02-28
• Primary completion: 2027-08-28
• Completion: 2027-08-28
• First posted: 2024-11-15
• Last updated: 2026-03-20

Locations

8 sites across 1 country: France