Newborn Monitoring, Physiologic Monitoring, Vital Signs Monitoring
Conditions
Keywords
Wireless monitoring, Vital signs, Newborn, Neonate, Delivery room, Wearable sensor, Electrocardiography, Respiratory rate, Skin temperature
Brief summary
This prospective observational study aims to evaluate the accuracy, safety, and feasibility of the Wireless MicroPremVitals Button Sensor System for continuous monitoring of electrocardiography (ECG), heart rate, respiratory rate, oxygen saturation, and skin temperature in newborn infants in the delivery room. Measurements obtained from the wireless sensor system will be compared with standard-of-care monitoring. The study will also assess skin tolerability, signal quality, and parent and healthcare provider perceptions of the device.
Interventions
DEVICEWireless MicroPremVitals Button Sensor
A wireless wearable sensor system applied to newborn infants in the delivery room to continuously measure electrocardiography (ECG), heart rate, respiratory rate, oxygen saturation, and skin temperature. Measurements will be compared with standard-of-care monitoring for validation purposes only and will not be used for clinical decision-making.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Years
Healthy volunteers
Yes
Inclusion criteria
\- Infants born by C-Section or vaginal delivery, with ≥35 weeks of gestational age and judged clinically stable immediately after birth.
Exclusion criteria
* Infants with skin abnormality would potentially increase the risk of injury. * Family experiencing too much stress as determined by an attending physician or bedside care team, to not be approached for recruitment. * Infants born at \<35 weeks gestational age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electrocardiography (ECG) Accuracy | During two 15-minute monitoring periods within the first 90 minutes after birth | Agreement between ECG measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor. |
| Skin Temperature Accuracy | During two 15-minute monitoring periods within the first 90 minutes after birth. | Agreement between skin temperature measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor. |
| Oxygen Saturation (SpO₂) Accuracy | During two 15-minute monitoring periods within the first 90 minutes after birth. | Agreement between oxygen saturation (SpO₂) measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Accuracy | During two 15-minute monitoring periods within the first 90 minutes after birth. | Heart rate will be calculated offline from raw optical and motion data collected by the Wireless MicroPremVitals Button Sensor System. Agreement between calculated heart rate and the standard-of-care Dräger Infinity M540 monitor will be evaluated. |
| Heart Rate Variability (HRV) | During two 15-minute monitoring periods within the first 90 minutes after birth. | Heart rate variability will be calculated offline from raw optical and motion data collected by the Wireless MicroPremVitals Button Sensor System. Derived HRV measurements will be compared with HRV derived from the standard-of-care Dräger Infinity M540 monitor. |
Contacts
CONTACTAlyssa Maximov, BSc.
PRINCIPAL_INVESTIGATORGuilherme Sant'Anna, MD, PhD
RI-MUHC
Outcome results
None listed