Actively Recruiting

Phase Not Applicable
Age: 3Years - 11Years
All Genders
NCT06442592

Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects

Led by Nantes University Hospital · Updated on 2026-04-03

1206

Participants Needed

5

Research Sites

160 weeks

Total Duration

On this page

Sponsors

N

Nantes University Hospital

Lead Sponsor

A

Angers University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The leading cause of birth defects, Congenital Heart Defects (CHD) affect 12 million people worldwide and 41,000 newborns/year in Europe. It's a major cause of life-long morbidity and mortality, and a crucial public health issue. More than 50% of childs born with critical CHD will develop Neurodevelopmental Disorders (NDs), requiring specific care and impairing quality of life. NDs corresponds to early and lasting disturbances in cognitive, affective and behavioral development, linked to abnormalities in brain development. They are heterogeneous, affecting language, learning, motor skills, intellectual efficiency, social cognition, attention, memory and executive functions, and are associated with psychosocial difficulties (adaptive behavior, social interactions). This hidden handicap is the main long-term sequels of CHD, even before cardiovascular sequels, in individuals who often underwent multiple heart operations in early childhood. NDs concern not only complex CHD, but also simple CHD repaired in childhood and considered cured. The origin of TND associated with CHD is largely unknown. To date, few genetic or environmental causes have been clearly identified, but recent work has suggested that a common origin may link cardiac malformation and neurodevelopmental abnormality. The CATAMARAN - Pediatrics project is designed to detect potential neurodevelopmental delays associated with CHD as early as age 3, and to identify individual susceptibility factors involved in the occurrence of NDs in CHD children.

CONDITIONS

Official Title

Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects

Who Can Participate

Age: 3Years - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child aged 3 to 11 years with critical congenital heart defect operated on during the first three months of life
  • Parents and child covered by social security or a similar scheme
  • Parents and child have a good understanding of the French language
  • Free, informed, and written consent given by both parents for themselves and the child
  • Free, informed, and written consent given by child aged 6 and over
  • Both biological parents
Not Eligible

You will not qualify if you...

  • Genetic anomaly or malformative syndrome linked to neurodevelopmental abnormalities identified before inclusion
  • Neurodevelopmental assessment cannot be performed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Chu Brest

Brest, Brittany Region, France, 29200

Actively Recruiting

2

CHU Rennes

Rennes, Brittany Region, France, 35000

Actively Recruiting

3

CHU Nantes

Nantes, Loire-Atlantique, France, 44000

Actively Recruiting

4

CHU Angers

Angers, Maine-et-Loire, France, 49000

Actively Recruiting

5

CHU Tours

Tours, Val de Loire, France, 37000

Actively Recruiting

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Research Team

A

Alban Baruteau

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects | DecenTrialz