Miniaturized Vital Sign Monitoring for Newborns in the Delivery Room

Starting soon

Conditions studied: Vital Signs Monitoring, Newborn Monitoring, Physiologic Monitoring

In brief

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 facts

Study ID

NCT07739810

Run by

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

People needed

5

Starts

2026-09-01

Expected to finish

2027-09-01

Last updated by the study team

2026-07-31

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Infants born by C-Section or vaginal delivery, with ≥35 weeks of gestational age and judged clinically stable immediately after birth.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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