NCT03931096

Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years

Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years : a Multicentre Controlled Cross-sectional Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 248 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 5 Years – 7 Years
• Healthy volunteers: Not accepted

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. Prevalence of " GUCH ", grown-ups with congenital heart disease has thus been significantly increasing. Nowadays, quality of life (QoL) assessment of this population is in the foreground. Our team is a reference center in the management of patient with CHD, from the fetal period to adulthood. The investigators have been conducting a clinical research program on health related QoL in pediatric and congenital heart disease. The investigators thus demonstrated the link between cardiopulmonary fitness and QoL in children with CHD aged 8 to 18 years, the correlation between functional class and QoL in adults with CHD, and the impact of therapeutic education on QoL in children under anticoagulants. Currently, no controlled cross-sectional quality of life study assessment has been leaded in the youngest children with CHD. This present study therefore extends our work in younger children aged 5 to 7 years.

Detailed description

248 patients will be enrolled in this study. Patient from groups 1 is included during his annual medical check-up. Quality of life questionnaire and other examinations are performed during this site visit. Its is a part of his usual care. No supplementary visit, directly related to the research, are necessary. 2 sites will participate to the enrollment, belonging to the French national network for complex congenital heart diseases (M3C) . Participants (healthy children) from groups 2 are included from schools.The prior agreement of the Ministry of National Education was obtained before any procedure related to this study. 3 schools will participate to the enrolment

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
OTHER	Quality of life questionnaire	Self and proxy PedsQL 4.0 questionnaires.

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-12-01
• Completion: 2019-12-31
• First posted: 2019-04-30
• Last updated: 2020-03-10

Locations

1 site across 1 country: France