Continuous body-temperature monitoring of preterm babies after birth using a wireless adhesive thermometer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter observational pilot study evaluates the feasibility, accuracy, and safety of the SteadyTemp adhesive thermometer for continuous, non-invasive temperature monitoring in moderately preterm infants (32+0 to 36+6 weeks) during the immediate postnatal transition. Temperature data from the adhesive sensor will be compared with routine rectal measurements and skin tolerability after removal will be assessed. Maternal intrapartum temperature will also be monitored to explore relationships between maternal and neonatal thermoregulation. The study enlists centers in Austria and Germany, with parent/legal guardian consent obtained prior to delivery. The aim is to determine whether continuous monitoring can improve detection of thermal instability beyond intermittent checks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Preterm neonates born between 32+0 and 36+6 weeks of gestation.
* Written informed consent obtained from the mother (or legally authorized representative, where applicable according to national legislation) before delivery and before any study-specific procedures are performed.

Exclusion Criteria:

* Gestational age \<32+0 weeks or ≥37+0 weeks.
* No decision to conduct full life support.
* Written informed consent not obtained before delivery.
* Congenital malformation.

Where it's running

• Medical University Graz
  Graz, Styria, Austria Recruiting

Study contacts

• Study coordinator: Nariae Baik-Schneditz, MD. PhD.
• Email: nariae.baik@medunigraz.at
• Phone: +43 316 385 82677

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.