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Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia

NCT07756892 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2026-08-11

No results posted yet for this study

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

Interventions

DEVICE

continous temperature measurement

continous temperature measurement

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Eligibility

Min Age
3 Days
Max Age
1 Week
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2028-08-15
Completion
2028-08-15

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07756892 on ClinicalTrials.gov