Miniaturized Vital Sign Monitoring for Newborns in the Delivery Room

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.

NCT Number	NCT07739810
Lead Sponsor	McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions	Vital Signs Monitoring, Newborn Monitoring, Physiologic Monitoring
Enrollment	5 participants
Start Date	2026-09-01
Primary Completion	2027-09-01 (estimated)
Study Completion	2027-09-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-31