NCT07732244 Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit
| NCT ID | NCT07732244 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Hypoxic-Ischemic Encephalopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-11-15 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-11-15 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.).
Eligibility Criteria
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.
Contact & Investigator
Guilherme Sant'Anna, MD, PhD
PRINCIPAL INVESTIGATOR
RI-MUHC
Frequently Asked Questions
Who can join the NCT07732244 clinical trial?
This trial is open to participants of all sexes, studying Hypoxic-Ischemic Encephalopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07732244 currently recruiting?
Yes, NCT07732244 is actively recruiting participants. Contact the research team at alyssa.maximov@muhc.mcgill.ca for enrollment information.
Where is the NCT07732244 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT07732244 clinical trial?
NCT07732244 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The principal investigator is Guilherme Sant'Anna, MD, PhD at RI-MUHC. The trial plans to enroll 20 participants.