About this trial
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
Qualifiers
None
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Wireless MicroPremVitals Button Sensor