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

Not yet recruiting

• Conditions: Heart Disease Congenital; Neurodevelopmental 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 neurodevelo...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-13
• Study First Posted: 2024-11-15
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Study Start: 2025-01-03
• Primary Completion: 2026-09-03
• Study Completion: 2026-09-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

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Exclusion Criteria

• Medical termination of pregnancy considered
• Genetic anomaly or malformative syndrome identified prior to inclusion

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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