Continuous Monitoring of Body Temperature in Mothers and Their Preterm Neonates (MonT NeoP)

August 12, 2026 updated by: Medical University of Graz

Continuous Monitoring of Body Temperature in Mothers and Their Preterm Neonates During the Immediate Postnatal Transition - A Prospective Observational Pilot Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicenter, observational pilot study conducted at the Medical University of Graz, Austria, and the University Hospital Essen, Germany, to evaluate the feasibility, performance, and safety of continuous non-invasive body temperature monitoring using the SteadyTemp® wireless adhesive thermometer in moderately preterm neonates during the immediate postnatal transition. In addition, maternal intrapartum body temperature will be continuously monitored to explore the relationship between maternal and neonatal thermal regulation during the perinatal period.

Maintaining normothermia immediately after birth is a key component of neonatal care, particularly for preterm infants, who are at increased risk of thermal instability because of immature thermoregulation, limited brown adipose tissue, and a high surface area-to-volume ratio. Both hypothermia and hyperthermia are associated with increased neonatal morbidity and mortality. Conventional temperature assessment methods provide only intermittent measurements and do not permit continuous monitoring during the critical transition after birth. The SteadyTemp® adhesive thermometer is a wireless, skin-adherent device that continuously records body temperature and transfers the data via near-field communication (NFC). Although the device has previously been evaluated in adults and term neonates, its feasibility and performance in preterm neonates have not yet been investigated.

Following informed consent before delivery, the SteadyTemp® adhesive thermometer will be applied to the mother at least 10 minutes before birth to enable continuous intrapartum temperature monitoring. Immediately after birth, a second SteadyTemp® adhesive thermometer will be applied to the right axillary region of the preterm neonate and will continuously record body temperature during the first 15 minutes of postnatal transition. After completion of monitoring, the adhesive patch will be removed and neonatal skin integrity will be assessed using the Neonatal Skin Condition Scale (NSCS). As part of routine clinical care, a single rectal body temperature measurement will be obtained using the locally established reference thermometer and used for comparison with the temperature recorded by the investigational device. No study-specific therapeutic interventions are performed beyond application of the adhesive thermometers.

The study plans to enroll 80 participants, comprising 40 mother-preterm neonate pairs. The sample size was determined to provide adequate precision for estimating the feasibility of continuous temperature monitoring based on results from a previous pilot study in term neonates. The study is intended to generate preliminary evidence regarding device feasibility, agreement with routine clinical temperature measurements, skin tolerability, and the relationship between maternal and neonatal temperatures to support the design of future confirmatory studies.

Statistical analyses will primarily be descriptive. Continuous variables will be summarized using means and standard deviations or medians and interquartile ranges, as appropriate, while categorical variables will be presented as counts and percentages. Feasibility will be reported as the proportion of successful uninterrupted temperature recordings with corresponding 95% confidence intervals. Agreement between SteadyTemp® and rectal temperature measurements will be evaluated using Bland-Altman analysis and correlation analysis. Skin tolerability will be summarized descriptively, and changes in skin condition will be assessed when baseline assessments are available. Associations between maternal intrapartum temperature and neonatal temperature during the immediate postnatal transition will be explored using correlation analyses and longitudinal linear mixed models adjusted for relevant clinical variables. Statistical analyses will be performed using R software, and a two-sided p-value <0.05 will be considered statistically significant.

Study data will be recorded in paper-based case report forms using pseudonymized participant identifiers. Personal data will be handled in accordance with applicable data protection regulations and archived for the legally required retention period. Data quality will be ensured through double verification of data entry and independent monitoring according to a predefined monitoring plan. Source data verification will be performed by comparing case report forms with original medical records in accordance with ISO(International Organization for Standardization) 14155, ICH(International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)-GCP(Good Clinical Practice), and applicable regulatory requirements. All study personnel will receive protocol-specific training, and written standard operating procedures will govern study conduct, data collection, monitoring, and use of the investigational device.

The Sponsor applies a risk-based quality management approach throughout the clinical investigation. Potential study-specific risks, protocol deviations, adverse events, and device deficiencies will be continuously monitored, documented, and managed in accordance with the clinical investigation plan and Regulation (EU) 2017/745. The study will be conducted in compliance with ISO 14155, ICH-GCP, the Declaration of Helsinki, and applicable national regulations governing clinical investigations of medical devices.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of continuous body temperature monitoring using the SteadyTemp® adhesive thermometer in preterm neonates
Time Frame: 15 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement between SteadyTemp® and rectal body temperature measurements
Time Frame: 15 minutes after birth (at the time of routine rectal temperature measurement).
Agreement between the temperature recorded by the SteadyTemp® adhesive thermometer and the single routine rectal temperature measurement will be assessed using Bland-Altman analysis and correlation analysis.
15 minutes after birth (at the time of routine rectal temperature measurement).
Neonatal skin tolerability after application of the SteadyTemp® adhesive thermometer
Time Frame: Immediately after removal of the adhesive thermometer (15 minutes after birth).
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
Time Frame: From approximately 10 minutes before birth until 15 minutes after birth.
Correlation between continuously measured maternal intrapartum temperature and neonatal body temperature during the first 15 minutes after birth.
From approximately 10 minutes before birth until 15 minutes after birth.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Universität Duisburg-Essen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

August 15, 2028

Study Completion (Estimated)

August 15, 2028

Study Registration Dates

First Submitted

August 6, 2026

First Submitted That Met QC Criteria

August 6, 2026

First Posted (Actual)

August 11, 2026

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 12, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1222/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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