Continuous Monitoring of Body Temperature in Mothers and Their Preterm Neonates

NCT07758205 | Not Yet Recruiting DMC

• 1 other identifier: 1222/2025
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

postnatal temperature; preterm neonate

Outcome Measures

Primary Outcomes (1)

• Feasibility of continuous body temperature monitoring using the SteadyTemp® adhesive thermometer in preterm neonates

  Feasibility will be assessed as the proportion of preterm neonates with successful placement of the SteadyTemp® adhesive thermometer and uninterrupted continuous body temperature recording during the first 15 minutes after birth.

  15 minutes

Secondary Outcomes (3)

• Agreement between SteadyTemp® and rectal body temperature measurements

  15 minutes after birth (at the time of routine rectal temperature measurement).

• Neonatal skin tolerability after application of the SteadyTemp® adhesive thermometer

  Immediately after removal of the adhesive thermometer (15 minutes after birth).

• Association between maternal intrapartum temperature and neonatal body temperature during immediate postnatal transition

  From approximately 10 minutes before birth until 15 minutes after birth.

Study Arms (1)

Mother-Preterm Neonate Pairs

The study cohort consists of mother-preterm neonate pairs. Preterm neonates will undergo continuous body temperature monitoring using the SteadyTemp® adhesive thermometer during the first 15 minutes after birth, while mothers will undergo continuous intrapartum temperature monitoring during delivery. Neonatal temperatures will be compared with a routine single rectal temperature measurement, and maternal and neonatal temperature profiles will be explored to assess their relationship during the immediate postnatal transition.

Device: Temperature monitoring

Interventions

Temperature monitoring DEVICE

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.

Mother-Preterm Neonate Pairs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of preterm neonates born between 32+0 and 36+6 weeks of gestation and their mothers at the Department of Obstetrics and Gynaecology of the Medical University of Graz, Austria, and the University Hospital Essen, Germany. Eligible mother-preterm neonate pairs will be recruited before delivery after written informed consent has been obtained. Neonates will undergo routine postnatal care, with additional continuous temperature monitoring using the investigational device during the immediate postnatal transition.

You may qualify if:

• Preterm neonates born between 32+0 and 36+6 weeks of gestation.
• Written informed consent obtained from the mother (or legally authorized representative, where applicable according to national legislation) before delivery and before any study-specific procedures are performed.

You may not qualify if:

• Gestational age \<32+0 weeks or ≥37+0 weeks.
• No decision to conduct full life support.
• Written informed consent not obtained before delivery.
• Congenital malformation.

Sponsors & Collaborators

• Medical University of Graz: lead
• Universität Duisburg-Essen: collaborator

Study Sites (1)

Medical University Graz

Graz, Styria, 8034, Austria

Location

Central Study Contacts

Nariae Baik-Schneditz, MD. PhD.

CONTACT

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

Lukas Mileder, MD.PhD.

CONTACT

lukas.mileder@medunigraz.at

Study Design

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

Study Record Dates

• First Submitted: August 6, 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)