Continuous Monitoring of Body Temperature in Neonates During Skin-to-skin Care Immediately After Cesarean Section (MonT Neo) (MonT Neo)

July 9, 2025 updated by: Medical University of Graz

Continuous Monitoring of Body Temperature in Neonates During Skin-to-skin Care Immediately After Cesarean Section (MonT Neo) - a Prospective Observational Pilot Study

The objective of this prospective observational pilot study is to apply the adhesive thermometer SteadyTemp® (SteadySense GmbH, Graz, Austria) in term neonates to monitor their body temperature non-invasively and continuously during skin-to-skin care with their mothers after Cesarean section and to compare these data with the one-time manual measurement of rectal body temperature as gold standard.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary aim: To apply the adhesive thermometer SteadyTemp® (SteadySense GmbH, Graz, Austria) in term neonates in the right axillary area immediately after birth and to monitor their body temperature continuously during skin-to-skin care with their mothers after Cesarean section for 15 minutes.

Secondary aim

  • To compare the body temperature with manually measured rectal temperature (single measurement).
  • To examine the skin condition under the adhesive patch after 15 minutes of application using the Neonatal Skin Condition Scale (NSCS)17.

Study Type

Observational

Enrollment (Actual)

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 Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8034
        • Medical University Graz

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

Yes

Sampling Method

Non-Probability Sample

Study Population

term neonates born per caesarean section immediately after birth

Description

Inclusion Criteria:

  • Term neonates after caesarean section receiving skin-to-skin care immediately after birth
  • Parental written informed consent

Exclusion Criteria:

  • Preterm birth
  • Need for respiratory support after birth
  • No decision to conduct full life support
  • No written informed consent
  • 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
term neonates
term neonates after Cesarean section
Device: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body temperature
Time Frame: up to 15 minutes after birth
body temperature continuously measured with SteadyTemp® (SteadySense GmbH, Graz, Austria)
up to 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

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 (Actual)

October 24, 2024

Primary Completion (Actual)

April 28, 2025

Study Completion (Actual)

April 28, 2025

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MonTNeo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We need Data transfer agreement, before we can share our study data

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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