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

Recruiting now

Conditions studied: Prematurity, Infections, NIRS, Near Infrared Spectroscopy, Preterm Neonates, Term Infant, Infection, Neonatal Sepsis, Early-Onset

In brief

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.

Key facts

Study ID

NCT07109856

Run by

Medical University of Graz

People needed

93

Starts

2025-11-27

Expected to finish

2028-05-01

Last updated by the study team

2026-05-14

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• birth weight ≥ 2000 grams
• Signs of respiratory distress at time-point of inclusion (tachypnoea >60/min, grunting, intercostal/subcostal/jugular retractions, nasal flaring, supplemental oxygen or respiratory support)
• Decision to conduct full life support
• Written informed consent obtained within the first 6 hours after birth, before inclusion in the study
• Age < 6 hours

You may not qualify if…

• No decision to conduct full life support
• No written informed consent
• Birth weight < 2000 grams
• Age > 6 hours
• Severe congenital malformations,
• Umbilical cord artery pH <7.20

Where it is running

• Medical University of Graz, Division of Neonatology — Graz, Styria, Austria (enrolling)

Full record on ClinicalTrials.gov

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