Miniaturized Vital Sign Monitoring for Newborns in the Delivery Room

Conditions: Vital Signs Monitoring, Newborn Monitoring, Physiologic Monitoring

Sex: All

Ages: N/A – 24 Hours

Healthy volunteers: Yes

Enrollment: 5

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

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.

Eligibility Criteria

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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07739810). StuddyBuddy aggregates publicly available trial information.