Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit

Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit: a Sub-study of the Wireless NICU Study

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.).

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease; Stroke Hemorrhagic; Hypoxic-Ischemic Encephalopathy; Aneurysm Cerebral
• Intervention / Treatment: Device: Wireless NIRS

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alyssa Maximov, BSc; Phone Number: 78229 5149341934; Email: alyssa.maximov@muhc.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3H2R9
      • Recruiting
      • Montreal Children's Hospital
      • Contact: Guilherme Sant'Anna, MD, PhD; Phone Number: 78229 5149341934; Email: guilherme.santanna@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Wireless Near-infrared spectroscopy (NIRS); Wireless NIRS applied to participant's forehead.	Device: Wireless NIRS; Wireless NIRS applied to participant forehead.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of SpO2 and Heart Rate (HR) data between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800).	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).	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.	Provide a a custom study questionnaire to capture the perspectives of clinicians and patients' parents/guardians regarding use of the wireless NIRS compared to wired NIRS device. The questionnaire includes Likert-scale items, multiple-choice questions, and open-ended responses evaluating usability, perceived safety, accuracy, comfort, and acceptability. Responses will be summarized descriptively by questionnaire item.	6 months

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Guilherme Sant'Anna, MD, PhD, RI-MUHC

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: July 27, 2026
• First Posted (Actual): July 28, 2026

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 27, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: NICU; Technology; NIRS; Near-Infrared Spectroscopy; Wireless Sensor
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Brain Ischemia; Congenital Abnormalities; Signs and Symptoms, Respiratory; Cardiovascular Abnormalities; Intracranial Arterial Diseases; Aneurysm; Stroke; Hypoxia, Brain; Hypoxia; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemorrhagic Stroke; Heart Defects, Congenital; Hypoxia-Ischemia, Brain; Intracranial Aneurysm
• Other Study ID Numbers: Wireless NIRS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No