Miniaturized Vital Sign Monitoring for Newborns in the Delivery Room

NCT07739810 | Not Yet Recruiting

• 1 other identifier: Button Sensors in the DR
• Study Type: observational
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Vital Signs Monitoring; Newborn Monitoring; Physiologic Monitoring

Keywords

Wireless monitoring; Vital signs; Newborn; Neonate; Delivery room; Wearable sensor; Electrocardiography; Respiratory rate; Skin temperature

Outcome Measures

Primary Outcomes (3)

• Electrocardiography (ECG) Accuracy

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

  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.

  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.

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

Secondary Outcomes (2)

• Heart Rate Accuracy

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

• Heart Rate Variability (HRV)

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

Study Arms (1)

Newborn Infants

Healthy newborn infants enrolled in the study who will undergo simultaneous monitoring with the Wireless MicroPremVitals Button Sensor System and standard-of-care monitoring in the delivery room to evaluate the accuracy, safety, and feasibility of the wireless monitoring system.

Device: Wireless MicroPremVitals Button Sensor

Interventions

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.

Newborn Infants

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy newborn infants in the delivery room at the study site who are eligible for routine delivery room monitoring and whose parent(s) or legal guardian provide informed consent for study participation.

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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Officials

• Guilherme Sant'Anna, MD, PhD

  RI-MUHC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa Maximov, BSc.

CONTACT

5149341934; alyssa.maximov@muhc.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share