An interventional study of Wireless MicroPremVitals Button Sensor System in Premature Birth, Fragility and Apnea of Prematurity, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Device feasibility
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.
Building on prior collaborative work between the Smart Hospital Project and the Dr. John Rogers Laboratory (QSIB- Northwestern University, Chicago, USA) in skin-integrated, soft, flexible electronics for premature infants, 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. By miniaturizing the hardware and tailoring form factor, weight, and interface materials for fragile neonatal skin, the system aims to extend wireless, clinical-grade monitoring down to the smallest, sickest babies.
In the NICU, the possible use of wireless sensors has received positive feedback from parents and HCPs. Overall, the perception is that eliminating the wires and cables will facilitate sensors application and monitoring, improve patient comfort, and skin-to-skin contact between infants and parents.
This proposal aims to:
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 10 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
The Wireless MicroPremVitals Button Sensor System consists of three (3) sensors: a chest unit, a forehead unit, and a limb unit. In this study, the MicroPremVitals Button forehead sensor will be mounted on the cerebral area of neonates at the level of the forehead. The chest unit will be mounted on the chest, between the nipples, or slightly below the nipple-line as placement allows. The limb unit will be mounted on the outer surface of the hand, wrist, or ankle of any limbs, as placement with standard wired equipment allows.
Device: Wireless MicroPremVitals Button Sensor System
The Wireless MicroPremVitals Button Sensor System consists of three (3) sensors: a chest unit, a forehead unit, and a limb unit. In this study, the MicroPremVitals Button forehead sensor will be mounted on the cerebral area of neonates at the level of the forehead. The chest unit will be mounted on the chest, between the nipples, or slightly below the nipple-line as placement allows. The limb unit will be mounted on the outer surface of the hand, wrist, or ankle of any limbs, as placement with standard wired equipment allows.
Device: 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.
HR Accuracy
Comparison of heart rate measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.
Time frame: 6 months
Oxygen Saturation Accuracy
Comparison of SpO₂ measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.
Time frame: 6 months
Skin Temperature Accuracy
Comparison of skin temperature measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.
Time frame: 6 months
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
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