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

Recruiting

• Conditions: Body Temperature Measurement
• Interventions: Device: No intervention

• Registration Number: NCT06632769
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-07
• Study First Posted: 2024-10-09
• Study Start: 2024-10-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-10-10
• Study Completion: 2025-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
term neonates	No intervention	term neonates after Cesarean section

Primary Outcome Measures

Name	Time	Method
body temperature	up to 15 minutes after birth	body temperature continuously measured with SteadyTemp® (SteadySense GmbH, Graz, Austria)

Trial Locations

Locations (1)

Medical University Graz; 🇦🇹 Graz, Styria, Austria