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Completed

NCT Number: NCT06632769

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

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.

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Key information

Conditions

Body Temperature Measurement

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Graz

Graz, Styria, 8034, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Intervention

Device

No intervention

Primary outcomes

  1. body temperature

    Time frame: up to 15 minutes after birth

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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Acronym: MonT Neo

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2024
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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