Support and characterization of neurodevelopmental disorders in newborns with congenital heart defects
CATAMARAN - Neonatal Cohort : Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal
This project will try to see how often and why babies with prenatally diagnosed critical congenital heart defects develop early neurodevelopmental problems by following them from before birth through infancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 8 sites (Nantes, Loire Atlantique and 7 other locations) |
| Trial ID | NCT06690151 on ClinicalTrials.gov |
What this trial studies
This observational, longitudinal project enrolls fetuses with prenatally diagnosed critical congenital heart defects and follows infants through the neonatal period and early infancy. Investigators collect clinical data (cardiac, fetal, pregnancy), biological samples for genetic analyses, and brain MRI when available. Standardized neurodevelopmental testing (Bayley-IV), parental questionnaires (including stress and diet tools), and repeated clinical follow-up are used to map developmental outcomes. The study aims to link clinical, imaging, genetic, and environmental factors to early neurodevelopmental trajectories in this high-risk group.
Who should consider this trial
Good fit: Ideal candidates are fetuses with a prenatal diagnosis of a critical congenital heart defect expected to require cardiac surgery within the first three months of life whose parents are French-speaking, covered by social security (or equivalent), and provide written informed consent.
Not a fit: Patients without a prenatal CHD diagnosis, those with noncritical or late-onset cardiac lesions, non–French-speaking families, or families unwilling to participate in follow-up or sample collection are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the work could enable earlier identification of infants at high risk for neurodevelopmental disorders and inform targeted follow-up and early interventions to improve outcomes.
How similar studies have performed: Previous cohorts have shown high rates of neurodevelopmental problems after congenital heart disease and identified some risk factors, but combining prenatal enrollment, trio genetics, MRI, and standardized neonatal Bayley testing makes this multimodal approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nantes, Loire Atlantique and 7 other locations
- Nantes University Hospital — Nantes, Loire Atlantique, France (Recruiting)
- CHU de Bordeaux — Bordeaux, France (Recruiting)
- APHP - Antoine Béclère — Clamart, France (Recruiting)
- Hôpital Marie Lannelongue — Le Plessis-Robinson, France (Recruiting)
- Ap-Hm — Marseille, France (Recruiting)
- AP-HP Necker — Paris, France (Not_yet_recruiting)
- CHU de Toulouse — Toulouse, France (Not_yet_recruiting)
- CHRU Tours — Tours, France (Recruiting)
Study contacts
- Study coordinator: Alban Baruteau
- Email: albanelouen.baruteau@chu-nantes.fr
- Phone: +33 2 40 08 77 42
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.