The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates

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.

NCT Number	NCT07109856
Lead Sponsor	Medical University of Graz
Conditions	Prematurity, Infections, NIRS, Near Infrared Spectroscopy, Preterm Neonates, Term Infant, Infection, Neonatal Sepsis, Early-Onset
Enrollment	93 participants
Start Date	2025-11-27
Primary Completion	2028-03-01 (estimated)
Study Completion	2028-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-14