Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06573203

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sleep Infant，newborn Vital Signs

Age range

1 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital Affiliated to the Medical College of Zhejiang University

Hangzhou, Zhejiang, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-contact heart rate and respiratory rate monitoring system

Device

Each neonate enrolled underwent four sleep and vital signs monitoring procedures after admission.

Other names: model YBB-B1

Mindray ECG monitor

Device

Heart rate and respiratory rate of each enrolled child were monitored after admission.

Other names: model cPM 10C

aEEG

Device

Each enrolled child underwent a 6-hour sleep-wake cycle, quiet sleep, and active sleep monitoring after admission.

Other names: model Nicolet EEG V32

Neonatal Sleep-Wake Assessment Tool (NSWAT) included four dimensions: eye movement, respiratory rate, facial expression and muscle activity.

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Other

Collaborators

  • Jiaxing Yuanbeibei Technology Co. LTD

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.