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Clinical Trials/NCT06632769
NCT06632769
Completed
Not Applicable

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

Medical University of Graz1 site in 1 country40 target enrollmentOctober 24, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Body Temperature Measurement
Sponsor
Medical University of Graz
Enrollment
40
Locations
1
Primary Endpoint
body temperature
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
October 24, 2024
End Date
April 28, 2025
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Medical University of Graz
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

body temperature

Time Frame: up to 15 minutes after birth

body temperature continuously measured with SteadyTemp® (SteadySense GmbH, Graz, Austria)

Study Sites (1)

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