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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06626594
Enrollment
0
Registered
2024-10-04
Start date
2024-12-01
Completion date
2025-02-01
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn Health, Sleep

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.

Interventions

None listed

Sponsors

The Children's Hospital of Zhejiang University School of Medicine
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No

Inclusion criteria

* The clinical definition of a newborn was met.

Exclusion criteria

* A state of persistent convulsions

Design outcomes

Primary

MeasureTime frameDescription
Neonatal sleep-wake state scores(composite outcome measure)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

MeasureTime frameDescription
Sleep state as shown by Amplitude-integrated EEGMeasurements were performed simultaneously with the Chinese version of the Neonatal Sleep-Wake Assessment Tool for 2minutes.The sleep-wake state of the newborn was obtained by aEEG analysis.The spectrum band of aEEG can be analyzed that the newborn is in a quiet sleep state, an active sleep state and an awake state. Generally, the narrow band refers to the awakening period and AS period, and the broad band refers to the QS period.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026