NCT06632769

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

October 24, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2025

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

October 7, 2024

Last Update Submit

July 9, 2025

Conditions

Body Temperature Measurement

Keywords

monitoringbody temperatureterm neonatestransitionskin-to-skin careCesarean section

Outcome Measures

Primary Outcomes (1)

  • body temperature

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

    up to 15 minutes after birth

Study Arms (1)

term neonates

term neonates after Cesarean section

Device: No intervention

Interventions

No interventionDEVICE

No intervention

term neonates

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

term neonates born per caesarean section immediately after birth

You may qualify if:

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

You may not qualify if:

  • Preterm birth
  • Need for respiratory support after birth
  • No decision to conduct full life support
  • No written informed consent
  • Congenital malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Graz

Graz, Styria, 8034, Austria

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 9, 2024

Study Start

October 24, 2024

Primary Completion

April 28, 2025

Study Completion

April 28, 2025

Last Updated

July 10, 2025

Record last verified: 2025-07

Locations

AU(1)