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NOT YET RECRUITING
NCT07739810

Miniaturized Vital Sign Monitoring for Newborns in the Delivery Room

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - 24 Hours

Study Type

OBSERVATIONAL

Enrollment

5

Start Date

2026-09-01

Completion Date

2027-09-01

Last Updated

2026-07-31

Healthy Volunteers

Yes

Interventions

DEVICE

Wireless 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.