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Could a wireless patch replace wires on tiny heads? a NICU trial puts it to the test

NCT ID NCT07732244

Knowledge-focused Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This study tests whether a wireless sensor placed on the forehead can accurately measure oxygen levels in the brains of infants in the neonatal intensive care unit (NICU). The wireless device is compared side-by-side with the standard wired monitor in 20 newborns with conditions like hypoxic-ischemic encephalopathy or congenital heart disease. If the wireless version works as well, it could mean fewer wires and less disturbance for these vulnerable babies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Wireless NIRS device
What this could lead to
If the wireless sensor proves reliable, it could reduce the tangle of wires around fragile newborns, making monitoring less disruptive.
What could go wrong
This is a small, early feasibility study with only 20 infants, so results may not apply broadly. The wireless device may not match the accuracy of the wired gold standard.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

brain aneurysm brain hypoxia - ischemia congenital heart disease hemorrhagic stroke intracerebral hemorrhage perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aneurysm cerebral Congenital heart disease Hypoxic-ischemic encephalopathy Stroke hemorrhagic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Montreal Children's Hospital

    RECRUITING

    Montreal, Quebec, H3H2R9, Canada

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