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Study identifier: NCT07109856 Synced from ClinicalTrials.gov · July 29, 2026
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The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates

Condition: Prematurity, Infections · NIRS · Near Infrared Spectroscopy  ·  Sponsor: Medical University of Graz

PhaseN/A
Planned participants93
Who can joinAll sexes, 0 Hours to 6 Hours
Healthy volunteersNo

About this study

This is a prospective, single-center Phase II observational study investigating the predictive value of the "Peripheral(-muscle) Oxygenation and Perfusion Score" (POP-Score), a novel non-invasive composite index, for early detection of infection/inflammation in neonates. The POP-Score combines peripheral muscle oxygenation measured via near-infrared spectroscopy (NIRS) with routinely monitored clinical parameters (heart rate, oxygen saturation, systolic blood pressure, and subcutaneous fat thickness). The study aims to determine the optimal cut-off value of the POP-Score measured within the first 6 hours after birth to predict elevated C-reactive protein (CRP ≥20 mg/L) within 48 hours. Additionally, multi-site NIRS measurements (cerebral, peripheral muscle, intestinal, and flank) will be evaluated to assess their association with inflammation. The study includes term and moderate-to-late preterm neonates (birth weight ≥2000g) with respiratory distress, admitted to the neonatal intensive care unit at the Medical University of Graz.

This description comes directly from the study's public registry record.

Talk to the study team

Christina H. Wolfsberger, MD, PhD  ·  +43 316 385 81135  ·  christina.wolfsberger@medunigraz.at

Gerhard Pichler, Prof  ·  gerhard.pichler@medunigraz.at

Always discuss trial participation with your own doctor first.

Locations (1)

Medical University of Graz, Division of NeonatologyGraz, Styria, AustriaRecruiting

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Source record: clinicaltrials.gov/study/NCT07109856