Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia

NCT07756892 | Not Yet Recruiting DMC

• 1 other identifier: 1167/2026
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Therapeutic Hypothermia; Neonatal Hypoxic-Ischemic Encephalopathy; Neonatal Thermal Management

Keywords

continous temperature measurement; neonate; hypothermia

Outcome Measures

Primary Outcomes (1)

• Body temperature

  Agreement between continuous body temperature measurements obtained with the SteadyTemp® adhesive thermometer and routine rectal temperature measurements during therapeutic hypothermia.

  During the monitoring period of approximately 7-10 hours during the rewarming phase of therapeutic hypothermia.

Secondary Outcomes (2)

• Ability of the SteadyTemp® adhesive thermometer to measure temperatures below 36°C during therapeutic hypothermia.

  Approximately 7-10 hours during the rewarming phase of therapeutic hypothermia.

• Skin condition after removal of the SteadyTemp® adhesive thermometer.

  Immediately after removal of the adhesive thermometer (approximately 10 hours after application).

Study Arms (1)

neonate with therapeutic hypothermia

neonate with therapeutic hypothermia

Device: continous temperature measurement

Interventions

continous temperature measurement DEVICE

continous temperature measurement

neonate with therapeutic hypothermia

Eligibility Criteria

• Age: 3 Days - 1 Week
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Gestational age \<36+0 weeks.
• No clinical indication for therapeutic hypothermia.
• Written informed consent not obtained from the parents or legal guardians.
• Congenital malformation.

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz

Graz, Styria, 8034, Austria

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nariae Baik-Schneditz, PhD. M.D.

CONTACT

+43 316 385 82677; nariae.baik@medunigraz.at

Lukas Mileder, PhD. M.D.

CONTACT

+43 316 385 81052; lukas.mileder@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): August 15, 2028
• Study Completion (Estimated): August 15, 2028
• Last Updated: August 11, 2026

Record last verified: 2026-08

Locations

AU (1)