Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years (QoL-CHD-5-7)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
• Children with CHD (as defined in the ACC-CHD classification) aged 5 to 7 years or same aged school children.
Exclusion criteria
- Other comorbidity affecting quality of life (polymalformative syndrome, extracardiac organ failure, neurodegenerative disease, severe genetic disease, psychomotor retardation).
- Surgical procedure during the last 6 months.
- Inability to understand the QoL questionnaire (parents and / or child): non-french speaker, severe intellectual disability.
Trial design
248 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal