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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

Recruitingn/aAges 0 Hours - 6 HoursAllMedical University of Graz
NCT07109856 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • POP-Score Assessment
  • Near-Infrared Spectroscopy (NIRS)
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Where

1 site
Medical University of Graz, Division of Neonatology
Graz, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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