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.
Study Type
OBSERVATIONAL
Enrollment
5
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.
Electrocardiography (ECG) Accuracy
Agreement between ECG measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor.
Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth
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.
Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.
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.
Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.
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.
Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.
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.
Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.
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