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

Not Applicable

Active, not recruiting

• Conditions: Sleep; Infant，newborn; Vital Signs
• Interventions: Device: Non-contact heart rate and respiratory rate monitoring system; Device: Mindray ECG monitor; Device: aEEG

• Registration Number: NCT06573203
• Lead Sponsor: The Children's Hospital of Zhejiang University School of Medicine

Brief 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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-20
• Study Start: 2024-08-21
• Study First Submitted QC: 2024-08-23
• Study First Posted: 2024-08-27
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-contact heart rate and respiratory rate monitoring system	aEEG	After admission, the non-contact mattress is placed under a normal mattress, and heart rate, respiratory rate, and sleep-related parameters can be collected through induction.
Neonatal Sleep-Wake Assessment Tool	Non-contact heart rate and respiratory rate monitoring system	It is suitable for all newborns to observe and evaluate the sleep phase, wake period and regularity, and guide the choice of care time. The scale includes four dimensions: eye movement, breathing rate, facial expression and muscle activity. The score range of each dimension is 0 \~ 2 points, and the score range is 0 \~ 8 points.
Non-contact heart rate and respiratory rate monitoring system	Mindray ECG monitor	After admission, the non-contact mattress is placed under a normal mattress, and heart rate, respiratory rate, and sleep-related parameters can be collected through induction.
Electrocardiogram monitor	Non-contact heart rate and respiratory rate monitoring system	Measuring vital signs
Amplitude-integrated EEG	Non-contact heart rate and respiratory rate monitoring system	Sleep parameters were continuously measured by aEEG for 6 hours after admission.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
Respiratory rate	The hospital stay lasted 6 hours	Respiratory rate was measured simultaneously by non-contact heart rate and respiratory rate monitoring system and electrocardiogram monitor for 6 hours, and the average respiratory rate was calculated.
Heart rate	The hospital stay lasted 6 hours	Heart rate was measured simultaneously by non-contact heart rate and respiratory rate monitoring system and electrocardiogram monitor for 6 hours, and the average heart rate was calculated.

Trial Locations

Locations (1)

The Children's Hospital Affiliated to the Medical College of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China