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Continuous Monitoring of Body Temperature in Mothers and Their Preterm Neonates

NCT07758205 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-08-11

No results posted yet for this study

Summary

Preterm babies are at increased risk of becoming too cold or too warm immediately after birth because they have an immature ability to regulate their body temperature. Maintaining a normal body temperature during the first minutes after birth is important because both low and high body temperatures are associated with an increased risk of complications. Current temperature monitoring is performed intermittently using conventional thermometers and does not provide continuous information about changes in body temperature.

This prospective observational pilot study aims to evaluate the feasibility of using the SteadyTemp® adhesive thermometer, a wireless, non-invasive temperature sensor, for continuous body temperature monitoring in preterm neonates (32+0 to 36+6 weeks of gestation) during the first 15 minutes after birth. The study will also compare temperatures recorded by the adhesive thermometer with a routine rectal temperature measurement and assess skin tolerability after removal of the adhesive patch. In addition, maternal body temperature will be continuously monitored during delivery to explore the relationship between maternal intrapartum temperature and neonatal temperature during the immediate postnatal transition.

The study hypothesizes that continuous temperature monitoring with the SteadyTemp® adhesive thermometer is feasible in preterm neonates, that the recorded temperatures agree with standard rectal temperature measurements, that the device is well tolerated without clinically relevant skin irritation, and that maternal intrapartum temperature correlates with neonatal body temperature during the immediate postnatal transition. The results of this pilot study will provide preliminary evidence to support future studies evaluating continuous, non-invasive temperature monitoring as a tool to improve thermal management of preterm neonates immediately after birth.

Conditions

  • Preterm Neonate
  • Temperature Monitoring

Interventions

DEVICE

Temperature monitoring

SteadyTemp® (SteadySense GmbH, Graz, Austria) is a wireless, non-invasive adhesive thermometer designed for continuous body temperature monitoring. In this study, one adhesive thermometer will be applied to the mother's skin at least 10 minutes before delivery for continuous intrapartum temperature monitoring, and a second thermometer will be applied to the preterm neonate's right axillary region immediately after birth for continuous temperature monitoring during the first 15 minutes of postnatal transition. Temperature data are recorded continuously and transferred via near-field communication (NFC). The device is used in addition to standard clinical care and does not replace routine rectal temperature measurement, which serves as the clinical reference standard.

Sponsors & Collaborators

  • Universität Duisburg-Essen

    collaborator OTHER

  • Medical University of Graz

    lead OTHER

Eligibility

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 NCT07758205 on ClinicalTrials.gov