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临床试验/NCT03432182
NCT03432182已完成不适用

Characterization of Movements Occurring During Sleep in Very Premature Neonates: Relationship With Neurodevelopmental Outcome

Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2018年2月28日最近更新:
适应症

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

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

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Michel HASCOET

Principal Investigator

Central Hospital, Nancy, France

研究点 (2)

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