Early Detection and Treatment of Obstructive Sleep Apnoea in Infants With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Median Griffiths Scales of Child Development, Third Edition (Griffiths III) Scores
研究概览
简要总结
Interventional, comparative, open-label, single-center study to demonstrate that early (from 6 months of age) and systematic (every 6 months) screening for Obstructive Sleep Apnoea (OSA) by polysomnography (PSG) in infants with Down syndrome during the first 3 years of life is associated with improved neurodevelopment at 3 years of age, with sustained benefits up to 5 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Down Syndrome Age 6 months or less for the Study Group Age 30 to 36 months for the Standard Care Group Living in Paris or Paris area (75, 77, 78, 92, 93, 94, 95) Parents or legal representative agreeing with the study requirements and able to understand, date and sign the informed consent form before study enrollment French language is native mother tongue
排除标准
- •Gestationnel age < 36 completed amenorrhoea weeks Patient who have or had acute CNS suffering signs Patients with Down Syndrome already had continuous positive airway pressure treatment for OSA Patients participating in another clinical study or for whom a participation to another biomedical research is expected before the end or their follow-up
研究组 & 干预措施
Study group
Will have a PSG at home every 6 months (± 1 month) from the age of 6 months until the age of 3 years.
干预措施: Polysomnography (PSG) (Diagnostic Test)
Standard Care Group
Will have a single PSG at home which will give a reference in the Down Syndrome population of 3 years old and will be used as reference to the study group
干预措施: Polysomnography (PSG) (Diagnostic Test)
结局指标
主要结局
Median Griffiths Scales of Child Development, Third Edition (Griffiths III) Scores
时间窗: At the age of 3 years
Median Griffiths III scores at the age of 3 years will be compared between the 2 groups
次要结局
未报告次要终点