Wireless MicroPremVitals Button Sensor in the NICU

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Wireless MicroPremVitals Button Sensor System

    Device

    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.

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Extremely Preterm InfantExperimental treatment 1 intervention
Group B: Micro Preterm InfantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

HR Accuracy

Comparison of heart rate measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.

Time frame
6 months
2

Oxygen Saturation Accuracy

Comparison of SpO₂ measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.

Time frame
6 months
3

Skin Temperature Accuracy

Comparison of skin temperature measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.

Time frame
6 months

Secondary outcomes

1

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.

Time frame
6 months

Other outcomes

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