RecruitingNCT07109856

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

The Peripheral(-Muscle) Oxygenation and Perfusion Score (POPScore) a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates - a Prospective Phase II Observational Study


Sponsor

Medical University of Graz

Enrollment

93 participants

Start Date

Nov 27, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 0 HoursMax Age: 6 Hours

Inclusion Criteria5

  • 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

Exclusion Criteria6

  • 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

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Interventions

DIAGNOSTIC_TESTPOP-Score Assessment

A non-invasive score calculated within the first 6 hours after birth using peripheral muscle oxygenation (pTOI, measured via near-infrared spectroscopy), heart rate, arterial oxygen saturation (SpO2), systolic blood pressure (SABP), and subcutaneous fat layer thickness. The score is evaluated for its ability to predict C-reactive protein (CRP) levels ≥ 20 mg/L within 48 hours.

DEVICENear-Infrared Spectroscopy (NIRS)

NIRS measurements are performed within 6 hours after birth using the NIRO 200NX device at four anatomical sites (forearm, forehead, infraumbilical region, and left flank). Measurements assess peripheral muscle, cerebral, intestinal, and flank oxygenation to identify possible differences in tissue perfusion associated with early inflammation or infection.


Locations(1)

Medical University of Graz, Division of Neonatology

Graz, Styria, Austria

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NCT07109856


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