This prospective observational pilot study aims to evaluate the feasibility, accuracy, and safety of the SteadyTemp® wireless adhesive thermometer for continuous, non-invasive body temperature monitoring in neonates undergoing therapeutic hypothermia following hypoxic-ischemic encephalopathy. Currently, body temperature during therapeutic hypothermia is monitored using an invasive rectal temperature probe, which carries risks such as tissue injury, perforation, infection, and patient discomfort.
The study will enroll ten neonates born at ≥36 weeks of gestation who require therapeutic hypothermia. During the rewarming phase of treatment, the SteadyTemp® adhesive thermometer will be applied to the right axillary area for approximately 10 hours while routine rectal temperature monitoring continues. Temperature measurements obtained with the adhesive thermometer will be compared with simultaneous rectal core temperature measurements. In addition, skin condition after removal of the adhesive patch will be assessed using the Neonatal Skin Condition Scale (NSCS) to evaluate local tolerability.
The study seeks to answer the following research questions:
Can the SteadyTemp® adhesive thermometer continuously and reliably monitor body temperature in neonates during therapeutic hypothermia? Do temperature measurements obtained with the non-invasive adhesive thermometer show sufficient agreement with standard invasive rectal temperature measurements, including temperatures below 36°C? Is prolonged application of the adhesive thermometer safe and well tolerated, without causing clinically relevant skin irritation?
The findings from this pilot study will provide preliminary evidence on the feasibility and agreement of this non-invasive monitoring method and will inform the design of larger validation studies investigating whether the SteadyTemp® adhesive thermometer could serve as a safe alternative to invasive rectal temperature monitoring during therapeutic hypothermia in neonates.
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.
Gestational age <36+0 weeks.
No clinical indication for therapeutic hypothermia.
Written informed consent not obtained from the parents or legal guardians.
Congenital malformation.
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.
Case-only
Prospective
continous temperature measurement
Devicecontinous temperature measurement
Body temperature
Agreement between continuous body temperature measurements obtained with the SteadyTemp® adhesive thermometer and routine rectal temperature measurements during therapeutic hypothermia.
Ability of the SteadyTemp® adhesive thermometer to measure temperatures below 36°C during therapeutic hypothermia.
Assessment of the performance of the SteadyTemp® adhesive thermometer for measuring body temperatures in the hypothermic range (down to approximately 33.5°C) by comparison with routine rectal temperature measurements.
Skin condition after removal of the SteadyTemp® adhesive thermometer.
Occurrence of skin irritation: Assessment of skin tolerability following approximately 10 hours of device application using the Neonatal Skin Condition Scale (NSCS).
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