Wireless MicroPremVitals Button Sensor in the NICU

NCT07732257 | Recruiting

• 1 other identifier: Wireless MicroPremVitals
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

ecg; vital sign; birth; neonate; resuscitation; prematurity; micropreterm; micropreemie

Outcome Measures

Primary Outcomes (3)

• HR Accuracy

  Comparison of heart rate measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.

  6 months

• Oxygen Saturation Accuracy

  Comparison of SpO₂ measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.

  6 months

• Skin Temperature Accuracy

  Comparison of skin temperature measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.

  6 months

Secondary Outcomes (1)

• Perspectives

  6 months

Study Arms (2)

Extremely Preterm Infant

EXPERIMENTAL

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 Infant

EXPERIMENTAL

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

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.

Extremely Preterm Infant; Micro Preterm Infant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Northwestern Querrey Simpson Institute for Bioelectronics (QSIB): collaborator

Study Sites (1)

Montreal Children's Hospital

Montreal, Quebec, H4A 3H9, Canada

RECRUITING

MeSH Terms

Conditions

Premature Birth; Apnea; Neonatal Sepsis

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes

Study Officials

• Guilherme Sant'Anna, MD, PhD

  The Research Institute of the McGill University Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa Maximov

CONTACT

5149341934; alyssa.maximov@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinician Scientist, Professor

Model Details: Micropreterm Infants / Extremely Preterm Infants

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: July 28, 2026
• Study Start: June 19, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

CA (1)