Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Congenital Heart Disease
- Type
- Observational
- Design
- Observational Model: Case-ControlTime Perspective: Cross-Sectional
Participation Requirements
- Age
- Between 2 years and 4 years
- Gender
- Both males and females
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 scale and clinical status will be assessed during this site visit. No supplementary visit, directly re...
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 scale and clinical status will be assessed during this site visit. No supplementary visit, directly related to the research, will be necessary. Three sites will participate to the study, members of he French national network for complex congenital heart diseases (M3C) . Participants (healthy children) from group 2 will be included from kindergartens and schools. The prior agreement of the Ministry of National Education will be obtained before any procedure related to this study.
Tracking Information
- NCT #
- NCT04812210
- Collaborators
- University of Montpellier - Inserm 1046 - PhyMeddExp
- Saint Pierre Institute - Palavas les Flots
- Congenital Cardiology Department of university hospital of Bordeaux
- Investigators
- Study Director: Pascal AMEDRO, MD-PhD UH MONTPELLIER Study Chair: Johanna Calderon PhyMeddExp Principal Investigator: Sophie Guillaumont Saint Pierre Institute - Palavas les Flots Principal Investigator: Jean-Benoit Thmabo Congenital Cardiology Department of university hospital of Bordeaux
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