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

March 3, 2025 updated by: Shujun Li, The Children's Hospital of Zhejiang University School of Medicine
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The Children's Hospital Affiliated to the Medical College of Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-contact heart rate and respiratory rate monitoring system
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.
Device: Mindray ECG monitor
Heart rate and respiratory rate of each enrolled child were monitored after admission.
Other Names:
  • model cPM 10C
Device: aEEG
Each enrolled child underwent a 6-hour sleep-wake cycle, quiet sleep, and active sleep monitoring after admission.
Other Names:
  • model Nicolet EEG V32
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.
Active Comparator: Electrocardiogram monitor
Measuring vital signs
Device: Non-contact heart rate and respiratory rate monitoring system
Each neonate enrolled underwent four sleep and vital signs monitoring procedures after admission.
Other Names:
  • model YBB-B1
Active Comparator: Amplitude-integrated EEG
Sleep parameters were continuously measured by aEEG for 6 hours after admission.
Device: Non-contact heart rate and respiratory rate monitoring system
Each neonate enrolled underwent four sleep and vital signs monitoring procedures after admission.
Other Names:
  • model YBB-B1
Active Comparator: Neonatal Sleep-Wake Assessment Tool
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.
Device: Non-contact heart rate and respiratory rate monitoring system
Each neonate enrolled underwent four sleep and vital signs monitoring procedures after admission.
Other Names:
  • model YBB-B1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep-wake state
Time Frame: 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.
10minutes after the meal, 5minutes each time, two times in total
Number of sleep cycles
Time Frame: 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.
The hospital stay lasted 6 hours
Proportion of quiet sleep
Time Frame: 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.
The hospital stay lasted 6 hours
Proportion of active sleep
Time Frame: 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.
The hospital stay lasted 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: 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.
The hospital stay lasted 6 hours
Respiratory rate
Time Frame: 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.
The hospital stay lasted 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Collaborators

Jiaxing Yuanbeibei Technology Co. LTD
Children's Hospital, Zhejiang University School of Medicine

Investigators

  • Principal Investigator: Hongzhen Xu, The Children's Hospital Affiliated to the Medical College of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-IEC-0024-P-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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