跳至主要内容
临床试验/NCT06626594
NCT06626594撤回不适用

Reliability and Validity of the Chinese Version of the Neonatal Sleep-Wake Assessment Tool

The Children's Hospital of Zhejiang University School of Medicine1 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
217
试验地点
1
主要终点
Neonatal sleep-wake state scores(composite outcome measure)

研究概览

简要总结

Sleep assessment of newborns in China is often neglected by medical staff, but sleep is related to the stability of vital signs and future neurobehavioral development. In order to understand the sleep quality of Chinese newborns and to protect their sleep during work, the neonatal sleep-wake assessment tool was translated into Chinese, revised, and tested for reliability and validity, in order to provide a reference for clinical staff to choose the timing of care.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •The clinical definition of a newborn was met.

排除标准

  • •A state of persistent convulsions

结局指标

主要结局

Neonatal sleep-wake state scores(composite outcome measure)

时间窗: Results observed within 2 minutes.

Behavioral state 4 items each scored and total score.The Chinese version of the Neonatal Sleep-Wake Assessment Tool included 4 items: eyes, breathing, facial expression, and movement. Each item was scored from 0 to 2 points, and the total score was from 0 to 8 points.Less than 3 points was defined as quiet sleep, 3-6 points as active sleep, and more than 6 points as awake sleep.

次要结局

  • Sleep state as shown by Amplitude-integrated EEG(Measurements were performed simultaneously with the Chinese version of the Neonatal Sleep-Wake Assessment Tool for 2minutes.)

研究者

发起方
The Children's Hospital of Zhejiang University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shujun Li

Honorary Director of Nursing Department

The Children's Hospital of Zhejiang University School of Medicine

研究点 (1)

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