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Recruiting NCT07732257

Wireless MicroPremVitals Button Sensor in the NICU

No phase Interventional Premature Birth Fragility Apnea of Prematurity Bradycardia Neonatal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Wireless MicroPremVitals Button Sensor System.
Who it may be relevant to
Registry conditions: Premature Birth, Fragility, Apnea of Prematurity, Bradycardia Neonatal. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Miniaturized Vital Sign Monitoring for Preterm Infants in the Neonatal Intensive Care Unit

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.

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

  • 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.

Primary outcome measures

  • HR Accuracy [Time frame: 6 months]
  • Oxygen Saturation Accuracy [Time frame: 6 months]
  • Skin Temperature Accuracy [Time frame: 6 months]
Secondary outcome measures (1)
  • Perspectives [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Device feasibility

Study locations

Canada · 1 center
  • Montreal Children's Hospital — Montreal

Identifiers

NCT: NCT07732257 · Wireless MicroPremVitals

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗