Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit

NCT07732244 | Recruiting

• 1 other identifier: Wireless NIRS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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; Stroke Hemorrhagic; Congenital Heart Disease; Aneurysm Cerebral

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Comparison of rStO2, data between the wireless NIRS and gold-standard wired NIRS.

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

  6 months

Secondary Outcomes (3)

• Comparison of SpO2 and Heart Rate (HR) data between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800).

  6 months

• Comparison of derived Heart Rate Variability (HRV) between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800).

  6 months

• Provide a questionnaire to capture the perspectives of clinicians and patients' parents/guardians regarding use of the wireless NIRS compared to wired NIRS device.

  6 months

Study Arms (1)

Wireless Near-infrared spectroscopy (NIRS)

OTHER

Wireless NIRS applied to participant's forehead.

Device: Wireless NIRS

Interventions

Wireless NIRS DEVICE

Wireless NIRS applied to participant forehead.

Wireless Near-infrared spectroscopy (NIRS)

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 ≥ 32 weeks at the time of the monitoring
• undergoing monitoring with the INVOS wired NIRS system.

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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal Children's Hospital

Montreal, Quebec, H3H2R9, Canada

RECRUITING

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Heart Defects, Congenital; Hemorrhagic Stroke; Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Stroke; Intracranial Arterial Diseases; Aneurysm

Study Officials

• Guilherme Sant'Anna, MD, PhD

  RI-MUHC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa Maximov, BSc

CONTACT

5149341934; alyssa.maximov@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: July 28, 2026
• Study Start: November 15, 2025
• Primary Completion: August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)