Wireless MicroPremVitals Button Sensor in the NICU | NCT07732257

NCT07732257

Overview

NCT ID: NCT07732257
Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
Official Title: Miniaturized Vital Sign Monitoring for Preterm Infants in the Neonatal Intensive Care Unit
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.
Conditions: Premature Birth
Fragility
Apnea of Prematurity
Bradycardia Neonatal
Sepses, Neonatal

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 28, 2026Actual
Start Date: Jun 19, 2026Actual
Primary Completion Date: Jan 30, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 10Estimated
Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Alyssa MaximovContact
alyssa.maximov@muhc.mcgill.ca5149341934 ext. 78229

Similar Studies

Participant Group/Arms

Extremely Preterm InfantExperimental

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

Micro Preterm InfantExperimental

Device: Wireless MicroPremVitals Button Sensor System