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Clinical Trials in China / NCT06573203
Active, not recruiting Not applicable

Clinical Effectiveness of Non-contact Heart Rate and Respiratory Rate Monitoring System

NCT06573203 · tracked via the Priya Life Science China tracker
Sponsor
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)

Trial sites (1)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT06573203 on ClinicalTrials.gov ↗ ← All trials in China