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Miniaturized Vital Sign Monitoring for Newborns in the Delivery Room

NCT07739810 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 5

Last updated 2026-07-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Guilherme Sant'Anna, MD, PhD · RI-MUHC

Eligibility

Max Age
24 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-09-01
Completion
2027-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07739810 on ClinicalTrials.gov