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

Recruitingn/aAges any - anyAllNantes University Hospital
NCT06690151 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 co

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📋 Eligibility rules (as published)
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
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What it tests

  • Neurodevelopmental assessment (Bayley-IV)
  • Biological sampling
  • ELFE dietary questionnaire
  • Post-Traumatic Stress Questionnaire IES-R (Impact of Event Scale - Revised)
  • Data collection for the study (Cardiovascular, developemental, fetal, pregnancy, MRI)
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Where

8 sites
Nantes University Hospital
Nantes, 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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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