Quality of Life and Quality of Sleep Studies in Children With Home Care Ventilation in Two Regions of France Pays de Loire and Bretagne
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Quality of life in children with home care ventilation
研究概览
简要总结
Home ventilation in children, invasive or non invasiv,e is an interesting treatment for different disease which cause chronic respiratory impairement. The aim of this treatment is to support alveolar hypoventilation. Concerned diseases are : neuro-muscular disease, upper airways pathologies, whest wall or lung pathologies, central control ventilation disease. Prevalence of home children ventilation is in augmentation in France. The last national study in 2021 about infants show a prevalence of 9.3/100 000. Advantages with home children ventilation in addition of improvement of survey, it can observe improvement of quality of life and improvement of the quality of their sleep. Quality of life is a thematic less studying. Last studies show an impairment of quality of life in all thematics compare to children with no disease but also with infants whith chronic diseases. This study were about few numbers of patients. The aim of this study is to evaluate the quality of life and the quality of sleep in children with home ventilation to complete the actual littérature to improve the respiratory care of this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child aged 6 months to 17 years treated with non-invasive ventilation at home for at least 1 month
- •Follow-up in one of the five centers participating in the study (Angers, Nantes, Le Mans, Rennes and Brest)
- •Informed consent form signed by both parents, or holder of parental authority, for the participation of their child
- •To be affiliated or beneficiary of social security
排除标准
- •Parents with poor command of the French language, implying not being able to complete the various questionnaires
- •Refusal of the child to participate in the study
研究组 & 干预措施
Children with home ventilation
干预措施: Quality of life and sleep questionnaire (Other)
结局指标
主要结局
Quality of life in children with home care ventilation
时间窗: 30 months
The quality of life of this population is assessed using the generic PedsQL 4.0 score. The questions are classified according to different categories regardless of age: physical capacity, emotional functioning, social relationships and schooling, or for children under 2 years old, relationship life and cognitive functioning. The evaluation relates to the past month. The questionnaire presents different questions depending on the age group
次要结局
未报告次要终点