Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years : a Multicentre Controlled Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Comparison of the total score of the proxy HRQoL questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 2 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Comparison of the total score of the proxy HRQoL questionnaire
时间窗: 1 day
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.
次要结局
- Comparison of score of the roxy HRQoL questionnaire(1 day)
- Comparison of score by dimensions of the proxy HRQoL questionnaire(1 day)
- Evaluation of the psychometric properties 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 of the association of the following variables related to the patient and to the CHD with the scores of the proxy HRQoL questionnaire(1 day)