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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Vital Signs Monitoring Newborn Monitoring Physiologic Monitoring

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Wireless MicroPremVitals Button Sensor

Device

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.

Primary outcomes

Electrocardiography (ECG) Accuracy

Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth

Agreement between ECG measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor.
Skin Temperature Accuracy

Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.

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

Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.

Agreement between oxygen saturation (SpO₂) measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor.

Secondary outcomes

Heart Rate Accuracy

Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.

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)

Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alyssa Maximov, BSc.

CONTACT

[email protected]

5149341934 ext. 78229

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jul 31, 2026
Registry last updated: Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting