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

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 Overview

• Status: Withdrawn
• Conditions: Sleep; Newborn Health

• Study Type: Observational

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • CHZhejiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All neonates admitted to the department of Neonatology and neonatal intensive care unit who met the definition of newborn.

Description

Inclusion Criteria:

• The clinical definition of a newborn was met.

Exclusion Criteria:

• A state of persistent convulsions

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients enrolled; All patients admitted to the neonatology department and neonatal intensive care unit were assessed for behavioral status using the Chinese version of the Neonatal Sleep-Wake Assessment Tool. Sleep cycles were also monitored using an electroencephalogram.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal sleep-wake state scores（composite outcome measure）	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.	Results observed within 2 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep state as shown by Amplitude-integrated EEG	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.	Measurements were performed simultaneously with the Chinese version of the Neonatal Sleep-Wake Assessment Tool for 2minutes.

Collaborators and Investigators

• Sponsor: The Children's Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-IEC-0024-P-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No