Wireless MicroPremVitals Button Sensor in the NICU

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study ID
NCT07732257
Status
Recruiting
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Conditions

  • Apnea of Prematurity
  • Bradycardia Neonatal
  • Fragility
  • Premature Birth
  • Sepses, Neonatal

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jul 28, 2026
Start date
Jun 19, 2026
Status verified
Jul 2026
Primary completion
Jan 30, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Extremely Preterm Infant
    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.
  • Experimental: Micro Preterm Infant
    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.

Primary Outcome Measure

HR Accuracy [ Time Frame: 6 months ]

Central Contacts

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