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

NCT06626594 | Withdrawn

• 1 other identifier: 2024-IEC-0024-P-02
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Newborn Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• The clinical definition of a newborn was met.

You may not qualify if:

• A state of persistent convulsions

Sponsors & Collaborators

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

Study Sites (1)

CHZhejiang

Hangzhou, Zhejiang, 310000, China

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Director of Nursing Department

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start: December 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: February 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

CN (1)