NCT06573203

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: The Children's Hospital of Zhejiang University School of Medicine · Academic / Other
• Sex: All
• Age: 1 Day – 1 Month
• Healthy volunteers: Not accepted

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.

Detailed description

The non-contact heart rate and respiratory rate monitoring system collected the body vibration signals of children through the heart rate and respiratory rate sensor, converted the pressure signals of vibration into electrical signals, extracted heart rate and respiratory rate, and extracted the characteristic parameters of sleep stages using heart rate and respiratory rate and body movement signals. It is characterized by no need to wear any equipment, the monitoring mattress is placed under the original baby mattress, no direct contact with the skin of the child, no comfort, and no change in the original sleep habits.

Conditions

• Sleep
• Infant，newborn
• Vital Signs

Interventions

Type	Name	Description
DEVICE	Non-contact heart rate and respiratory rate monitoring system	Each neonate enrolled underwent four sleep and vital signs monitoring procedures after admission.
DEVICE	Mindray ECG monitor	Heart rate and respiratory rate of each enrolled child were monitored after admission.
DEVICE	aEEG	Each enrolled child underwent a 6-hour sleep-wake cycle, quiet sleep, and active sleep monitoring after admission.
OTHER	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.

Timeline

• Start date: 2024-08-21
• Primary completion: 2026-08-31
• Completion: 2026-12-31
• First posted: 2024-08-27
• Last updated: 2025-03-05

Locations

1 site across 1 country: China