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

NCT ID: NCT04812210

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 248 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-12-30

Brief 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.

Detailed 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.

Conditions

Congenital Heart Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

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

No interventions assigned to this group

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

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Montpellier - Inserm 1046 - PhyMeddExp

UNKNOWN

Sponsor Role: collaborator

Saint Pierre Institute - Palavas les Flots

UNKNOWN

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal AMEDRO, MD-PhD

Role: STUDY_DIRECTOR

UH MONTPELLIER

Johanna Calderon

Role: STUDY_CHAIR

PhyMeddExp

Sophie Guillaumont

Role: PRINCIPAL_INVESTIGATOR

Saint Pierre Institute - Palavas les Flots

Jean-Benoit Thmabo

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

Uh Montpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL21_0083

Identifier Type: -

Identifier Source: org_study_id