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NCT Number: NCT07732244

Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit

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.).

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Key information

Conditions

Hypoxic-Ischemic Encephalopathy Aneurysm Aneurysm Cerebral Brain Diseases Brain Ischemia Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hemorrhagic Stroke Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Stroke Stroke Hemorrhagic Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Children's Hospital

Montreal, Quebec, H3H2R9, Canada

Location status: Recruiting

Location contact

Guilherme Sant'Anna, MD, PhD

CONTACT

[email protected]

5149341934 ext. 78229

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wireless NIRS

Device

Wireless NIRS applied to participant forehead.

Primary outcomes

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

    Time frame: 6 months

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

Secondary outcomes

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

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

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alyssa Maximov, BSc

CONTACT

[email protected]

5149341934 ext. 78229

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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