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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-21

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Sleep Infant，newborn Vital Signs

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mindray ECG monitor

Intervention Type DEVICE

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

aEEG

Intervention Type DEVICE

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

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

Intervention Type 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.

Electrocardiogram monitor

Measuring vital signs

Group Type ACTIVE_COMPARATOR

Non-contact heart rate and respiratory rate monitoring system

Intervention Type DEVICE

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

Amplitude-integrated EEG

Sleep parameters were continuously measured by aEEG for 6 hours after admission.

Group Type ACTIVE_COMPARATOR

Non-contact heart rate and respiratory rate monitoring system

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Non-contact heart rate and respiratory rate monitoring system

Intervention Type DEVICE

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

Interventions

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Non-contact heart rate and respiratory rate monitoring system

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

Intervention Type DEVICE

Mindray ECG monitor

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

Intervention Type DEVICE

aEEG

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

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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model YBB-B1 model cPM 10C model Nicolet EEG V32

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No