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.
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
No decision to conduct full life support
No written informed consent
Birth weight < 2000 grams
Age > 6 hours
Term and moderate-to-late preterm neonates (birth weight ≥ 2000 grams) with signs of respiratory distress within the first 6 hours after birth, admitted to the neonatal intensive care unit at the Medical University of Graz. All participants must have a gestational age allowing for clinical stability and must meet inclusion criteria including full life support decision and informed consent obtained within 6 hours of birth.
Cohort
Prospective
POP-Score Assessment
Diagnostic testA 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.
Near-Infrared Spectroscopy (NIRS)
DeviceNIRS 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.
Optimal Cut-Off Value of the POP-Score to Predict Elevated CRP (≥ 20 mg/L)
Determine the optimal cut-off value of the non-invasive POP-Score (unitless score), measured within the first 6 hours after birth, to predict elevated C-reactive protein (CRP) levels (≥ 20 mg/L) within the first 48 hours after birth in neonates with respiratory distress.
Difference in Peripheral Muscle Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP
Evaluate whether there are significant differences in peripheral muscle tissue oxygenation values measured via near-infrared spectroscopy (NIRS) within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \< 20 mg/L. Unit of Measure: % tissue oxygen saturation
Difference in Cerebral Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP
Evaluate whether there are significant differences in cerebral tissue oxygenation values measured via near-infrared spectroscopy (NIRS) within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \< 20 mg/L. Unit of Measure: % tissue oxygen saturation
Difference in Intestinal Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP
Evaluate whether there are significant differences in intestinal tissue oxygenation values measured via near-infrared spectroscopy (NIRS) within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \< 20 mg/L. Unit of Measure: % tissue oxygen saturation
Difference in Flank Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP
Evaluate whether there are significant differences in flank tissue oxygenation values measured via near-infrared spectroscopy (NIRS) within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \< 20 mg/L. Unit of Measure: % tissue oxygen saturation
Difference in Cerebral Fractional Tissue Oxygen Extraction (cFTOE) Between Neonates With and Without Elevated CRP
Assess whether there are significant differences in cerebral fractional tissue oxygen extraction (cFTOE) values, derived from near-infrared spectroscopy (NIRS), within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \< 20 mg/L. Unit of Measure: Unitless ratio
Difference in Peripheral Muscle Fractional Tissue Oxygen Extraction (pFTOE) Between Neonates With and Without Elevated CRP
Assess whether there are significant differences in peripheral muscle fractional tissue oxygen extraction (pFTOE) values, derived from NIRS, within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \< 20 mg/L. Unit of Measure: Unitless ratio
Difference in Intestinal Fractional Tissue Oxygen Extraction (sFTOE) Between Neonates With and Without Elevated CRP
Assess whether there are significant differences in intestinal fractional tissue oxygen extraction (sFTOE) values, derived from NIRS, within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \< 20 mg/L. Unit of Measure: Unitless ratio
Difference in Flank Fractional Tissue Oxygen Extraction (rFTOE) Between Neonates With and Without Elevated CRP
Assess whether there are significant differences in flank fractional tissue oxygen extraction (rFTOE) values, derived from NIRS, within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \< 20 mg/L. Unit of Measure: Unitless ratio
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