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

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.

Conditions

• Sleep
• Infant，newborn
• Vital Signs

Interventions

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.

Sponsors & Collaborators

• Jiaxing Yuanbeibei Technology Co. LTD

  collaborator UNKNOWN

• Children's Hospital, Zhejiang University School of Medicine

  collaborator UNKNOWN

• The Children's Hospital of Zhejiang University School of Medicine

  lead OTHER

Principal Investigators

• Hongzhen Xu · The Children's Hospital Affiliated to the Medical College of Zhejiang University

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

1 Month

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-21

Primary Completion

2026-08-31

Completion

2026-12-31

Countries

• China

Study Locations