Continuous Monitoring of Body Temperature in Neonates Dur... | NCT06632769

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

NCT06632769

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

Jul 10, 2025Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Body Temperature Measurement

Interventions

No intervention

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 24, 2024Actual

Primary Completion Date

Apr 28, 2025Actual

Completion Date

Apr 28, 2025Actual

First Submitted Date

Oct 7, 2024

First Submission Date that Met QC Criteria

Oct 7, 2024

First Posted Date

Oct 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2025

Last Update Posted Date

Jul 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
term neonates		term neonates after Cesarean section	Device: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Device	No intervention	term neonates

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

term neonates born per caesarean section immediately after birth

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University Graz		Graz	Styria	8034	Austria

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided