Hypoxic-Ischemic EncephalopathyNCT07732244
Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit
A study testing Wireless NIRS in people with Hypoxic-Ischemic Encephalopathy and Congenital Heart Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Congenital Heart Disease, Stroke Hemorrhagic
- What is being tested?
- Wireless NIRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Montreal Children's Hospital
Montreal, Quebec, H3H2R9
Guilherme Sant'Anna, MD, PhD, 5149341934 ext. 78229, guilherme.santanna@mcgill.ca
About this study
Official title: 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.).
- Conditions
- Hypoxic-Ischemic Encephalopathy, Congenital Heart Disease, Stroke Hemorrhagic, Aneurysm Cerebral
- Being tested
- Wireless NIRS
- Keywords
- NIRS, Near-Infrared Spectroscopy, Wireless Sensor, Technology, NICU
- Medical subject headings
- Hypoxia-Ischemia, Brain, Heart Defects, Congenital, Hemorrhagic Stroke, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless NIRSDevice
Wireless NIRS applied to participant forehead.
| Study group | Role | What they receive |
|---|---|---|
| Wireless Near-infrared spectroscopy (NIRS) | Other | Wireless NIRS applied to participant's forehead. Receives: Device: Wireless NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Comparison of SpO2 and Heart Rate (HR) data between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800).
Measured: 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).
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start15 Nov 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Sant'Anna, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Guilherme Sant'Anna, MD, PhD, Principal investigator, RI-MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732244
- Sponsor's protocol ID
- Wireless NIRS
- Status last verified
- Jul 2026
- First submitted
- 5 May 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit: a Sub-study of the Wireless NICU Study
- ClinicalTrials.gov ID
- NCT07732244
- Acronym / sponsor ID
- Wireless NIRS
- Conditions
- Hypoxic-Ischemic Encephalopathy, Congenital Heart Disease, Stroke Hemorrhagic, Aneurysm Cerebral
- Keywords
- NIRS, Near-Infrared Spectroscopy, Wireless Sensor, Technology, NICU
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wireless Near-infrared spectroscopy (NIRS) | Other | Device: Wireless NIRSWireless NIRS applied to participant's forehead. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wireless NIRSWireless NIRS applied to participant forehead. | Device | Wireless Near-infrared spectroscopy (NIRS) |
Primary outcome
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.
3 secondary outcomes
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 derived Heart Rate Variability (HRV) between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800).
Time frame: 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.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Hypoxic-Ischemic Encephalopathy
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Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
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Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
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A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Neonatal Seizure, Neonatal Encephalopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guilherme Sant'Anna, MD, PhD principal investigator
RI-MUHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wireless NIRS in people with Hypoxic-Ischemic Encephalopathy and Congenital Heart Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alyssa Maximov, BSc (5149341934 ext. 78229, alyssa.maximov@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of rStO2, data between the wireless NIRS and gold-standard wired NIRS. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.