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

NCT04812210 | Completed

• 1 other identifier: RECHMPL21_0083
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

health related quality of life; pediatrics; cardiology

Outcome Measures

Primary Outcomes (1)

• Comparison of the total score of the proxy HRQoL questionnaire

  Comparison of the total score of the proxy HRQoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) between patients with CHD and control children : The proxy HRQoL questionnaire PedsQL 4.0 is composed of 23 items comprising 4 demensions. Items are reversed scored and linearly transformed to a 0-100 scale. In order to get a total score we must sum all the items scores over the number of items answered on all the Scales. If more than 50% of the items in the scale are missing, the scale scores should not be computed.

  1 day

Secondary Outcomes (7)

• Comparison of score by dimensions of the proxy HRQoL questionnaire

  1 day

• Comparison of score of the roxy HRQoL questionnaire

  1 day

• Comparison of score of the proxy HRQoL questionnaire

  1 day

• Comparison of score of the HRQoL questionnaire

  1 day

• Comparison of score of the proxy HRQoL questionnaire

  1 day

Study Arms (2)

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

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

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

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

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• Children aged 2 to 4 years old.
• Group 2 : Chldren with CHD (as defined in the ACC-CHD classification).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• University of Montpellier - Inserm 1046 - PhyMeddExp: collaborator
• Saint Pierre Institute - Palavas les Flots: collaborator
• University Hospital, Bordeaux: collaborator

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pascal AMEDRO, MD-PhD

  UH MONTPELLIER

  STUDY DIRECTOR

• Johanna Calderon

  PhyMeddExp

  STUDY CHAIR

• Sophie Guillaumont

  Saint Pierre Institute - Palavas les Flots

  PRINCIPAL INVESTIGATOR

• Jean-Benoit Thmabo

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: April 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

FR (1)