Clinical trial NCT04812210: Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years
Official title: Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years : a Multicentre Controlled Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: health related quality of life
pediatrics
cardiology
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: University of Montpellier - Inserm 1046 - PhyMeddExp
name: Saint Pierre Institute - Palavas les Flots
name: University Hospital, Bordeaux
First posted: 2021-03-23
Enrollment: 248
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Groupe 1 : Children with congenital heart disease aged 2 to 4 years Groupe 2 : Healthy children aged 2 to 4 years

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.

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.

Primary outcomes:
measure: Comparison of the total score of the proxy HRQoL questionnaire
timeFrame: 1 day
Secondary outcomes:
measure: Comparison of score by dimensions of the proxy HRQoL questionnaire
timeFrame: 1 day
measure: Comparison of score of the roxy HRQoL questionnaire
timeFrame: 1 day
measure: Comparison of score of the proxy HRQoL questionnaire
timeFrame: 1 day
measure: Comparison of score of the HRQoL questionnaire
timeFrame: 1 day
measure: Comparison of score of the proxy HRQoL questionnaire
timeFrame: 1 day
measure: Study of the association of the following variables related to the patient and to the CHD with the scores of the proxy HRQoL questionnaire
timeFrame: 1 day
measure: Evaluation of the psychometric properties of the proxy HRQoL questionnaire
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: UH MONTPELLIER
name: Pascal AMEDRO, MD-PhD
role: STUDY_DIRECTOR
affiliation: PhyMeddExp
name: Johanna Calderon
role: STUDY_CHAIR
affiliation: Saint Pierre Institute - Palavas les Flots
name: Sophie Guillaumont
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Jean-Benoit Thmabo
role: PRINCIPAL_INVESTIGATOR
References: