Clinical Effectiveness of Non-contact Heart Rate and Respiratory Rate Monitoring System
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2024
CompletedStudy Start
First participant enrolled
August 21, 2024
CompletedFirst Posted
Study publicly available on registry
August 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 5, 2025
August 1, 2024
2 years
August 20, 2024
March 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Sleep-wake state
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
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
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
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 Outcomes (2)
Heart rate
The hospital stay lasted 6 hours
Respiratory rate
The hospital stay lasted 6 hours
Study Arms (4)
Non-contact heart rate and respiratory rate monitoring system
EXPERIMENTALAfter 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
ACTIVE COMPARATORMeasuring vital signs
Amplitude-integrated EEG
ACTIVE COMPARATORSleep parameters were continuously measured by aEEG for 6 hours after admission.
Neonatal Sleep-Wake Assessment Tool
ACTIVE COMPARATORIt 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.
Interventions
Each neonate enrolled underwent four sleep and vital signs monitoring procedures after admission.
Heart rate and respiratory rate of each enrolled child were monitored after admission.
Each enrolled child underwent a 6-hour sleep-wake cycle, quiet sleep, and active sleep monitoring after admission.
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.
Eligibility Criteria
You may qualify if:
- Newborns admitted to our hospital for the first time, with gestational age ≥28w;
- Expected hospital stay ≥5 days.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Children's Hospital Affiliated to the Medical College of Zhejiang University
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongzhen Xu
The Children's Hospital Affiliated to the Medical College of Zhejiang University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Honorary Director of Nursing Department
Study Record Dates
First Submitted
August 20, 2024
First Posted
August 27, 2024
Study Start
August 21, 2024
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 5, 2025
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share