Characterization of Movements Occurring During Sleep in Very Premature Neonates: Relationship With Neurodevelopmental Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Body movements evaluation during sleep
研究概览
简要总结
Sleep is a key factor for normal brain development of the newborn. However, it is poorly studied and little is known about its characterization, especially in premature infants. Body movements during sleep are easy to evaluate but studies on their relationship to normal sleep states are scarce and limited. This project aims to characterize body movements during sleep, assessed by electroencephalography, in very premature infants. Then, a correlation between body movements, sleep organization and neurodevelopmental outcome will be evaluated at 3 years of age.
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
- 10 Days 至 15 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born between 26 and 32 weeks gestation
排除标准
- •Genetic abnormality
- •Neurological pathology such as intraventricular hemorrhage > grade 2
- •Any medication know for altering electroencephalography recording
结局指标
主要结局
Body movements evaluation during sleep
时间窗: 3 months
number of movements observed according to sleep states
次要结局
- Sleep states organization(3 months)
- Type of movements observed during sleep(3 months)
- Neurodevelopmental outcome(3 years)
研究者
Jean-Michel HASCOET
Principal Investigator
Central Hospital, Nancy, France
