Apnea of Prematurity, Bradycardia Neonatal, Fragility, Premature Birth, Sepses, Neonatal
Conditions
Keywords
ecg, vital sign, birth, neonate, resuscitation, prematurity, micropreterm, micropreemie
Brief 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.
Detailed description
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.
Interventions
DEVICEWireless 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.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Northwestern Querrey Simpson Institute for Bioelectronics (QSIB)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Micropreterm Infants / Extremely Preterm Infants
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perspectives | 6 months | 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. |
Countries
Canada
Contacts
CONTACTAlyssa Maximov
PRINCIPAL_INVESTIGATORGuilherme Sant'Anna, MD, PhD
The Research Institute of the McGill University Health Center
Outcome results
None listed