Premature BirthFragilityApnea of PrematurityBradycardia NeonatalSepses, Neonatal
Investigational drug(s) / intervention(s)
Wireless MicroPremVitals Button Sensor System
Wireless MicroPremVitals Button Sensor System: These 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.
Study summary
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
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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,
* and/or not meeting all requirements of clinical stability,
* and/or with the Neonatal Nurse Practitioner (i.e., NNP)/Healthcare Team in disagreement for the patient to participate in the study.
Primary outcome measure(s)
HR Accuracy — 6 months Comparison of heart rate measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.
Oxygen Saturation Accuracy — 6 months Comparison of SpO₂ measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.
Skin Temperature Accuracy — 6 months Comparison of skin temperature measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.
Trial sites (1)
Facility
City
Region
Status
Montreal Children's Hospital
Montreal
Quebec
Recruiting
More McGill University Health Centre/Research Institute of the McGill University Health Centre trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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