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

University Hospital Center (CHU)

Status: Completed

Conditions: Congenital Heart Disease

Study type: Observational

Funder types: Other

Identifiers

NCT04812210

RECHMPL21_0083

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. 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.

Full 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 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.

Enrollment: 248 patients

Sex: All

Ages: 2 to 4 years old

Volunteers: No Healthy Volunteers

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.

Trial design

248 participants in 2 patient groups

case: children with congenital heart disease aged 2 to 4 years.

Description:

case: children with congenital heart disease aged 2 to 4 years.

control children recruited in kindergartens and schools aged 2 to 4 years

Description:

control children recruited in kindergartens and schools aged 2 to 4 years