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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06632769
Acronym
MonT Neo
Enrollment
40
Registered
2024-10-09
Start date
2024-10-24
Completion date
2025-04-28
Last updated
2025-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Temperature Measurement

Keywords

monitoring, body temperature, term neonates, transition, skin-to-skin care, Cesarean section

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.

Interventions

DEVICENo intervention

No intervention

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
body temperatureup to 15 minutes after birthbody temperature continuously measured with SteadyTemp® (SteadySense GmbH, Graz, Austria)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026