Recruiting

MicroPremVitalsWireless MicroPremVitals Button Sensor in the NICU

Sponsor:

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

Code:

NCT07732257

Conditions

Premature Birth

Fragility

Apnea of Prematurity

Bradycardia Neonatal

Sepses, Neonatal

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Wireless MicroPremVitals Button Sensor System

Study Details

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

Study ID

NCT07732257

Start date

Jun 19, 2026

Status verified date

Jul, 2026

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

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

Interventions

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 measure

HR Accuracy [ Time Frame: 6 months ]
Oxygen Saturation Accuracy [ Time Frame: 6 months ]
Skin Temperature Accuracy [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Alyssa Maximov

5149341934 alyssa.maximov@muhc.mcgill.ca

Locations

Montreal Children's Hospital

Recruiting

Montreal, Quebec, Canada, H4A 3H9

Contacts

Alyssa Maximov

5149341934 alyssa.maximov@muhc.mcgill.ca

Principal Investigator:

Guilherme Sant'Anna, MD, PhD

More Information

Sponsor

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

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

ecg
vital sign
birth
neonate
resuscitation
prematurity
micropreterm
micropreemie

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-07-28.