Recruiting

NIRS Sensor

Sponsor:

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

Code:

NCT07732244

Conditions

Hypoxic-Ischemic Encephalopathy

Congenital Heart Disease

Stroke Hemorrhagic

Aneurysm Cerebral

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Wireless NIRS

Study Details

Brief 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.).

Conditions

Hypoxic-Ischemic Encephalopathy

Congenital Heart Disease

Stroke Hemorrhagic

Aneurysm Cerebral

Study ID

NCT07732244

Start date

Nov 15, 2025

Status verified date

Jul, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Wireless Near-infrared spectroscopy (NIRS)

Wireless NIRS applied to participant's forehead.

Interventions

Wireless NIRS

Wireless NIRS applied to participant forehead.

Primary outcome measure

  • Comparison of rStO2, data between the wireless NIRS and gold-standard wired NIRS. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Alyssa Maximov, BSc

5149341934alyssa.maximov@muhc.mcgill.ca

Locations

Montreal Children's Hospital

Recruiting

Montreal, Quebec, Canada, H3H2R9

Contacts

Guilherme Sant'Anna, MD, PhD

5149341934guilherme.santanna@mcgill.ca

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

  • NIRS
  • Near-Infrared Spectroscopy
  • Wireless Sensor
  • Technology
  • NICU

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.