Status:
COMPLETED
Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
University of Montpellier - Inserm 1046 - PhyMeddExp
Saint Pierre Institute - Palavas les Flots
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
2-4 years
Brief Summary
Congenital heart diseases (CHD) are the firt cause of congenital malformations (8 for 1000 births). Since the 90's, great advances in prenatal diagnosis, pediatric cardiac surgery, intensive care, and...
Detailed Description
248 patients will be enrolled in this study (124 children in each group). Patients from group 1 will be included during their annual medical check-up. HRQoL questionnaire, neurodevelopmental status s...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Children aged 2 to 4 years old.
- Group 2 : Chldren with CHD (as defined in the ACC-CHD classification).
- Exclusion criteria:
- Other comorbidity affecting quality of life (polymalformative syndrome, extracardiac organ failure, severe genetic disease).
- Surgical procedure during the last 6 months.
- Inability to understand the HRQoL questionnaire (parents) :non-french speaker, severe intellectual disability.
Exclusion
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT04812210
Start Date
April 1 2021
End Date
December 30 2021
Last Update
April 12 2022
Active Locations (1)
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1
Uh Montpellier
Montpellier, France, 34295