Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit

NCT07732244 · tracked via the Priya Life Science Canada tracker

Sponsor

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

Phase

Not applicable

Started

2025-11-15

Last updated

2026-07-28

Condition(s) studied

Hypoxic-Ischemic EncephalopathyCongenital Heart DiseaseStroke HemorrhagicAneurysm Cerebral

Investigational drug(s) / intervention(s)

Wireless NIRS

Wireless NIRS: Wireless NIRS applied to participant forehead.

Study summary

The wireless NIRS sensor will be placed on the participant's forehead, directly underneath the INVOS wired sensor. The wireless NIRS sensor will remain in place for 4 consecutive hours, over 2 consecutive days. As standard-of-care, nursing personnel removes all sensors at every care to evaluate skin and reduce the risk of pressure sores. The wireless NIRS device will be removed and reapplied at the same time, by the research team who will annotate what time the sensor was removed, replaced, and the condition of the skin. This will be used to correlate signal disconnection with sensor care (i.e., skin checks, sensor removal, etc.).

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * Infants admitted to the NICU with a gestational age of ≥ 32 weeks at the time of the monitoring * undergoing monitoring with the INVOS wired NIRS system. 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.

Primary outcome measure(s)

Comparison of rStO2, data between the wireless NIRS and gold-standard wired NIRS. — 6 months
Comparison of rStO2, data between the wireless NIRS and gold-standard wired NIRS.

Trial sites (1)

Facility	City	Region	Status
Montreal Children's Hospital	Montreal	Quebec	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07732244 on ClinicalTrials.gov ↗ ← All trials in Canada