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.
None
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.
Healthy newborn infants in the delivery room at the study site who are eligible for routine delivery room monitoring and whose parent(s) or legal guardian provide informed consent for study participation.
Cohort
Prospective
Wireless MicroPremVitals Button Sensor
DeviceA 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.
Electrocardiography (ECG) Accuracy
Agreement between ECG measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor.
Skin Temperature Accuracy
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
Agreement between oxygen saturation (SpO₂) measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor.
Heart Rate Accuracy
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)
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.
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