The Children's Hospital of Zhejiang University School of Medicine
Phase
Not applicable
Started
2024-08-21
Last updated
2025-03-05
Condition(s) studied
SleepInfant,newbornVital Signs
Investigational drug(s) / intervention(s)
Non-contact heart rate and respiratory rate monitoring systemMindray ECG monitoraEEGNeonatal Sleep-Wake Assessment Tool (NSWAT) included four dimensions: eye movement, respiratory rate, facial expression and muscle activity.
Non-contact heart rate and respiratory rate monitoring system: Each neonate enrolled underwent four sleep and vital signs monitoring procedures after admission.
Mindray ECG monitor: Heart rate and respiratory rate of each enrolled child were monitored after admission.
aEEG: Each enrolled child underwent a 6-hour sleep-wake cycle, quiet sleep, and active sleep monitoring after admission.
Neonatal Sleep-Wake Assessment Tool (NSWAT) included four dimensions: eye movement, respiratory rate, facial expression and muscle activity.: The study nurses observed and scored the children's sleep-wake status 10 minutes after two meals during the mattress test period, each time for 5 minutes.
Study summary
In this study, hospitalized neonates were taken as the focus of the study. The non-contact heart rate and respiratory rate monitoring system was used to measure heart rate, respiratory rate, sleep parameters, ECG monitor, neonatal sleep-wake scale, amplitude-integrated electroencephalography. aEEG), in order to provide a theoretical basis for standardizing the operation of medical staff and formulating sleep protection strategies in the future, so as to promote the sleep quality of hospitalized neonates and improve the prognosis of neonates.
Eligibility
Sex
ALL
Min age
1 Day
Max age
1 Month
Healthy volunteers
No
Inclusion Criteria:
* Newborns admitted to our hospital for the first time, with gestational age ≥28w;
* Expected hospital stay ≥5 days.
Exclusion Criteria:
* Apgar score ≤3 at 1 or 5 min after birth;
* Severe congenital malformation; Severe hypoxic-ischemic encephalopathy, intraventricular hemorrhage of grade III and above; There were serious heart and lung diseases.
Primary outcome measure(s)
Sleep-wake state — 10minutes after the meal, 5minutes each time, two times in total Sleep-wake state scores derived from a contact-free heart rate and respiratory rate monitoring system and NSWST measurements.
Number of sleep cycles — The hospital stay lasted 6 hours The number of sleep cycles obtained was monitored simultaneously by a non-contact heart rate and respiratory rate monitoring system and aEEG.
Proportion of quiet sleep — The hospital stay lasted 6 hours non-contact heart rate and respiratory rate monitoring system and aEEG were used to simultaneously measure the quiet sleep time for 6 hours, and then the proportion of quiet sleep was calculated.
Proportion of active sleep — The hospital stay lasted 6 hours non-contact heart rate and respiratory rate monitoring system and aEEG were used to simultaneously measure the active sleep time for 6 hours, and then the proportion of active sleep was calculated.
Trial sites (1)
Facility
City
Region
Status
The Children's Hospital Affiliated to the Medical College of Zhejiang University
Hangzhou
Zhejiang
More The Children's Hospital of Zhejiang University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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