About this trial
A wireless and miniaturized vital sign (ECG, SpO2, Skin Temperature) sensor system, MicroPremVitals Button Sensors was developed by the Dr. John Rogers Laboratory (QSIB- Northwestern University, Chicago, USA) to facilitate vital sign monitoring in extremely preterm neonates.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infants admitted to the NICU with a gestational age of ≥ 22+0 weeks and ≤ 29+6 weeks at birth,
AND >72h of age at time of study,
AND clinically stable,
AND with the Neonatal Nurse Practitioner (i.e., NNP) and Healthcare Team in agreement for the patient to participate in the study.
Disqualifiers
Infants with a skin abnormality that would potentially increase the risk of injury,
patient too unstable or family experiencing too much stress as determined by an attending physician or bedside care team to not be approached for recruitment.
Infants admitted to the NICU with a gestational age of < 22+0 weeks or > 29+6 weeks at birth,
and/or ≤ 72h of age at time of study,
Trial design
Parallel
Treatments tested in this trial
Wireless MicroPremVitals Button Sensor System
DeviceThese button-sized sensors are designed to provide continuous ECG, oxygen saturation (SpO₂), and skin temperature monitoring without the bulky wires and large adhesives that impact the most fragile infants.
Treatment groups
Trial outcomes
Primary outcomes
HR Accuracy
Comparison of heart rate measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.
Oxygen Saturation Accuracy
Comparison of SpO₂ measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.
Skin Temperature Accuracy
Comparison of skin temperature measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.
Secondary outcomes
Perspectives
Clinician and parent/guardian perspectives on both the Wireless MicroPremVitals Button Sensor System and the wired vital sign monitoring system, will be assessed using a custom study questionnaire. The questionnaire includes Likert-scale items, multiple-choice questions, and open-ended responses evaluating usability, perceived safety, accuracy, comfort, and acceptability. Responses will be summarized descriptively by questionnaire item.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead sponsor
Northwestern Querrey Simpson Institute for Bioelectronics (QSIB)
Collaborator