Actively Recruiting
The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates
Led by Medical University of Graz · Updated on 2026-05-14
93
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Birth weight at least 2000 grams
- Signs of respiratory distress at inclusion (such as rapid breathing over 60/min, grunting, chest retractions, nasal flaring, or need for oxygen/respiratory support)
- Decision to provide full life support
- Written informed consent obtained within 6 hours after birth
- Age less than 6 hours
You will not qualify if you...
- No decision to provide full life support
- No written informed consent
- Birth weight less than 2000 grams
- Age more than 6 hours
- Severe congenital malformations
- Umbilical artery pH less than 7.20
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medical University of Graz, Division of Neonatology
Graz, Styria, Austria, 8036
Actively Recruiting
Research Team
C
Christina H. Wolfsberger, MD, PhD
CONTACT
G
Gerhard Pichler, Prof
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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