Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study ID
NCT07732244
Status
Recruiting
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Conditions

  • Aneurysm Cerebral
  • Congenital Heart Disease
  • Hypoxic-Ischemic Encephalopathy
  • Stroke Hemorrhagic

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Wireless NIRS — DEVICE
    Wireless NIRS applied to participant forehead.

Study Details

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.).

Key Dates

First listed
Jul 28, 2026
Start date
Nov 15, 2025
Status verified
Jul 2026
Primary completion
Aug 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Wireless Near-infrared spectroscopy (NIRS)
    Wireless NIRS applied to participant's forehead.

Primary Outcome Measure

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

Central Contacts

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