Continuous skin temperature monitoring in newborns during therapeutic hypothermia
Official title: Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia - A Prospective Observational Pilot Study
Run by Medical University of Graz · NCT07756892 · Data updated 2026-11-12
This study tests whether a wireless adhesive thermometer can safely and accurately monitor temperature in term and near-term newborns receiving therapeutic cooling.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Days to 1 Week |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz, Styria) |
| Status | Recruiting |
| Started | August 5, 2026 |
| Main results expected | August 15, 2028 |
| Study ends | August 15, 2028 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT07756892 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Neonates born at 36 weeks gestation or more who require therapeutic hypothermia for hypoxic-ischemic encephalopathy and whose parents have provided informed consent.
✕Probably not a fit
Patients not meeting gestational age criteria or not requiring therapeutic hypothermia may not benefit, and some may not experience improved monitoring accuracy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center observational pilot evaluates the feasibility, accuracy, and safety of the SteadyTemp wireless adhesive thermometer for continuous non-invasive temperature monitoring in neonates undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy. Temperature will be recorded via the adhesive sensor on the right axilla for about 10 hours during rewarming, with simultaneous rectal measurements as the reference standard. The study compares the adhesive thermometer readings with core rectal temperatures and examines skin condition after device removal. Enrollment targets ten neonates born at ≥36 weeks’ gestation with a clinical indication for therapeutic hypothermia, under parental consent.
Why it matters
Potential benefit: If successful, this non-invasive method could reduce the need for invasive rectal probes and associated risks while providing reliable temperature monitoring during hypothermia.
How similar studies have gone: Prior work shows potential for wireless skin sensors in term neonates under normal temperatures, but this application during therapeutic hypothermia is novel and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Medical University Graz
Graz, Styria, Austria Recruiting
Study contacts
- Study coordinator: Nariae Baik-Schneditz, PhD. M.D.
- Email: nariae.baik@medunigraz.at
- Phone: +43 316 385 82677
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.