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

M

Medical University of Graz

Status

Completed

Conditions

Body Temperature Measurement

Treatments

Device: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT06632769
MonTNeo

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

40 participants in 1 patient group

term neonates
Description:
term neonates after Cesarean section
Treatment:
Device: No intervention

Trial contacts and locations

1

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Central trial contact

Nariae Baik-Schneditz, MD. PhD.; Lukas Mileder, MD. PhD.

Data sourced from clinicaltrials.gov

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