Clinical Research Directory

Continuous Monitoring of Body Temperature in Mothers and Their Preterm Neonates

Preterm babies are at increased risk of becoming too cold or too warm immediately after birth because they have an immature ability to regulate their body temperature. Maintaining a normal body temperature during the first minutes after birth is important because both low and high body temperatures are associated with an increased risk of complications. Current temperature monitoring is performed intermittently using conventional thermometers and does not provide continuous information about changes in body temperature. This prospective observational pilot study aims to evaluate the feasibility of using the SteadyTemp® adhesive thermometer, a wireless, non-invasive temperature sensor, for continuous body temperature monitoring in preterm neonates (32+0 to 36+6 weeks of gestation) during the first 15 minutes after birth. The study will also compare temperatures recorded by the adhesive thermometer with a routine rectal temperature measurement and assess skin tolerability after removal of the adhesive patch. In addition, maternal body temperature will be continuously monitored during delivery to explore the relationship between maternal intrapartum temperature and neonatal temperature during the immediate postnatal transition. The study hypothesizes that continuous temperature monitoring with the SteadyTemp® adhesive thermometer is feasible in preterm neonates, that the recorded temperatures agree with standard rectal temperature measurements, that the device is well tolerated without clinically relevant skin irritation, and that maternal intrapartum temperature correlates with neonatal body temperature during the immediate postnatal transition. The results of this pilot study will provide preliminary evidence to support future studies evaluating continuous, non-invasive temperature monitoring as a tool to improve thermal management of preterm neonates immediately after birth.

Non-invasive Temperature Monitoring in Pediatric Intensive Care Patients Requiring Targeted Temperature Management: Evaluation of Temple Touch Pro

The purpose of this study is to evaluate the Temple Touch Pro (TTP) in Pediatric Intensive Care Unity (PICU) patients requiring targeted temperature control.

Clinical Accuracy Validation of the Moni-Patc Temperature Monitoring Patch During Surgery (Compared With Esophageal and Bladder Temperature)

Moni-Patc Temperature Monitoring Patch System, a non-invasive, continuous temperature monitoring device designed to estimate core body temperature by applying a Sensor to the neck.This clinical accuracy validation study aims to verify the accuracy and repeatability of the Moni-Patch compared with an FDA-cleared continuous esophageal and bladder temperature monitoring device used as the clinical reference.Main ObjectivesTo verify that the Moni-Patch and the reference device(esophageal and bladder) demonstrate acceptable agreement, as defined by Bland-Altman Analyses (bias within ±0.4°C and limits of agreement between -1.0°C and 1.0°C).To verify the consistency and repeatability of temperature measurements obtained from the Moni-Patch during continuous monitoring.