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

Key facts

Who runs it
Nantes University Hospital
Where
France8 sites in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
450 people, planned
Started
28 Feb 2025
Expected to end
28 Aug 2028
Type of study
Observational
Treatments tested
  • 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)
Record updated
1 July 2026

Who can take part

Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who cannot take part

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

Other 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.'

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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.

The group in the trial

  • Study population (Newborns with congenital heart defects and their two parents)

    The study population will consist of 150 fetuses with a prenatally diagnosed critical congenital heart defect (CHD), at high risk of developing developmental delays, and their two parents.

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
CATAMARAN - Neonatal Cohort : Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal
Publications
Record updated
1 July 2026