Wireless MicroPremVitals Button Sensor in the NICU

McGill University Health Centre/Research Institute of the McGill University Health Centre10 enrolled

Overview

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: 1. Investigate the feasibility, safety, and accuracy of the Wireless MicroPremVitals Button Sensors monitoring system specifically developed for use in extremely preterm neonates. 2. Assess parents and HCPs perspectives on standard and wireless vital sign monitoring systems in extremely preterm infants.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.

Time frame: 6 months

Wireless MicroPremVitals Button Sensor in the NICU

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts