An observational study in Sleep and Newborn Health, sponsored by The Children's Hospital of Zhejiang University School of Medicine. Withdrawn at 1 site in China. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by The Children's Hospital of Zhejiang University School of Medicine · Observational
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.
The Children's Hospital of Zhejiang University School of Medicine is the lead sponsor of 68 studies on the registry; 51 are open to participants now.
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All neonates admitted to the department of Neonatology and neonatal intensive care unit who met the definition of newborn.
Exclusion Criteria:
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.
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.
Time frame: Results observed within 2 minutes.
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.
Time frame: Measurements were performed simultaneously with the Chinese version of the Neonatal Sleep-Wake Assessment Tool for 2minutes.
Plan to share: Undecided
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This study is withdrawn, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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The Children's Hospital of Zhejiang University School of Medicine