Clinical trial NCT06573203: Clinical Effectiveness of Non-contact Heart Rate and Respiratory Rate Monitoring System
Official title: Clinical Effectiveness of Non-contact Heart Rate and Respiratory Rate Monitoring System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep
Infant，newborn
Vital Signs
Keywords: Sleep monitoring
Vital signs were monitored
Study of correlation
Lead sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
Collaborators: name: Jiaxing Yuanbeibei Technology Co. LTD
name: Children's Hospital, Zhejiang University School of Medicine
First posted: 2024-08-27
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep-wake state
timeFrame: 10minutes after the meal, 5minutes each time, two times in total
measure: Number of sleep cycles
timeFrame: The hospital stay lasted 6 hours
measure: Proportion of quiet sleep
timeFrame: The hospital stay lasted 6 hours
measure: Proportion of active sleep
timeFrame: The hospital stay lasted 6 hours
Secondary outcomes:
measure: Heart rate
timeFrame: The hospital stay lasted 6 hours
measure: Respiratory rate
timeFrame: The hospital stay lasted 6 hours
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Children's Hospital Affiliated to the Medical College of Zhejiang University
state: Zhejiang
Study officials:
affiliation: The Children's Hospital Affiliated to the Medical College of Zhejiang University
name: Hongzhen Xu
role: PRINCIPAL_INVESTIGATOR
References: