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Could a sticky patch replace invasive temperature probes in newborns?

NCT ID NCT07756892

Knowledge-focused Sponsor: Medical University of Graz Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This pilot study is testing whether a wireless adhesive thermometer can safely and accurately monitor body temperature in newborns undergoing therapeutic hypothermia, a cooling treatment for brain injury. Currently, temperature is tracked with an invasive rectal probe, which carries risks of injury and infection. The study will place the adhesive patch on the baby's armpit during rewarming and compare its readings with the standard rectal measurements, while also checking the skin for irritation. The goal is to see if this non-invasive approach could be a viable alternative for continuous temperature monitoring in these fragile infants.

What this could mean

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

Active substance
SteadyTemp® wireless adhesive thermometer for continuous, non-invasive body temperature monitoring
What this could lead to
If it works, this could replace invasive rectal temperature probes with a gentler, safer way to monitor newborns during cooling therapy.
What could go wrong
This is a very small pilot study, so results may not be conclusive. The adhesive patch might cause skin irritation or fail to match rectal readings accurately.

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.

Participants

About 10 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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.

Who is studied

The study population consists of term and near-term neonates (≥36+0 weeks of gestation) born at the Department of Obstetrics and Gynaecology, Medical University of Graz, Austria, who require therapeutic hypothermia for the management of hypoxic-ischemic encephalopathy. Eligible participants will be recruited during their admission to the neonatal intensive care unit after written informed consent has been obtained from their parents or legal guardians.

Ages

3 days to 1 week

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: * Neonates born at ≥36+0 weeks of gestation. * Clinical indication for therapeutic hypothermia. * Written informed consent obtained from the parents or legal guardians before study measurements are initiated. Exclusion Criteria: * Gestational age \<36+0 weeks. * No clinical indication for therapeutic hypothermia. * Written informed consent not obtained from the parents or legal guardians. * Congenital malformation.

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Conditions

The condition(s) this trial relates to.

Hypothermia perinatal asphyxia

As listed by the trial registrant

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

Neonatal hypoxic-ischemic encephalopathy Neonatal thermal management Therapeutic hypothermia

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

  • Medical University Graz

    Graz, Styria, 8034, Austria

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