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Clinical trial Recruiting at 6 sites Observational

Support and characterization of neurodevelopmental disorders in newborns with congenital heart defects

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

Run by Nantes University Hospital · NCT06690151 · Data updated 2026-11-12

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 typeObservational
SexAll
Enrollment450 (estimated)
SponsorNantes University Hospital
Academic / other
Locations8 sites (Nantes, Loire Atlantique and 7 other locations)
StatusRecruiting
StartedFebruary 28, 2025
Main results expectedAugust 28, 2028
Study endsAugust 28, 2028
Registry record updatedJuly 1, 2026
Trial IDNCT06690151 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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
  • CHRU Tours
    Tours, France     Recruiting
Show 2 more locations
  • AP-HP Necker
    Paris, France     Not yet recruiting
  • CHU de Toulouse
    Toulouse, France     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Neurodevelopmental Disorder 3Nantes University Hospital 144
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.