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Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years

NCT04812210 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 248

Last updated 2022-04-12

No results posted yet for this study

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 cardiac catheterization have reduced morbidity and early mortality in this population. Nowadays, health-related quality of life (HRQoL) assessment of this population is in the foreground. Our team is a tertiary care center for management of patients with CHD, from the fetal period to adulthood. The investigators have been conducting a clinical research program on HRQoL in pediatric and CHD. The investigators thus demonstrated the link between cardiopulmonary fitness and HRQoL in children with CHD aged 8 to 18 years, the correlation between functional class and HRQoL in adults with CHD, the impact of therapeutic education on HRQoL in children under anticoagulants and the lack of difference between the HRQoL of children CHD aged 5 to 7 years old and that of control children. Currently, no controlled cross-sectional quality of life study assessment has been leded in the youngest children with CHD. This present study therefore extends our work in younger children aged 2 to 4 years.

Conditions

  • Congenital Heart Disease

Sponsors & Collaborators

  • University of Montpellier - Inserm 1046 - PhyMeddExp

    collaborator UNKNOWN

  • Saint Pierre Institute - Palavas les Flots

    collaborator UNKNOWN

  • University Hospital, Bordeaux

    collaborator OTHER

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Pascal AMEDRO, MD-PhD · UH MONTPELLIER

  • Johanna Calderon · PhyMeddExp

  • Sophie Guillaumont · Saint Pierre Institute - Palavas les Flots

  • Jean-Benoit Thmabo · University Hospital, Bordeaux

Eligibility

Min Age
2 Years
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-12-01
Completion
2021-12-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04812210 on ClinicalTrials.gov