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

NCT ID: NCT06632769

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-24

Study Completion Date

2025-04-28

Brief Summary

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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

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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.

Conditions

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Body Temperature Measurement

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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term neonates

term neonates after Cesarean section

No intervention

Intervention Type DEVICE

No intervention

Interventions

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No intervention

No intervention

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University Graz

Graz, Styria, Austria

Site Status

Countries

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Austria

Other Identifiers

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MonTNeo

Identifier Type: -

Identifier Source: org_study_id

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