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Clinical Trials/NCT06626594
NCT06626594WithdrawnNot Applicable

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

The Children's Hospital of Zhejiang University School of Medicine1 site in 1 country217 target enrollmentStarted: December 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Enrollment
217
Locations
1
Primary Endpoint
Neonatal sleep-wake state scores(composite outcome measure)

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
1 Day to 28 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •The clinical definition of a newborn was met.

Exclusion Criteria

  • •A state of persistent convulsions

Outcomes

Primary Outcomes

Neonatal sleep-wake state scores(composite outcome measure)

Time Frame: 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.

Secondary Outcomes

  • 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.)

Investigators

Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shujun Li

Honorary Director of Nursing Department

The Children's Hospital of Zhejiang University School of Medicine

Study Sites (1)

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