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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-6
SponsorMedical University of Graz

About this trial

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 criteria

Qualifiers

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

Disqualifiers

No decision to conduct full life support

No written informed consent

Birth weight < 2000 grams

Age > 6 hours

Trial design

Treatments tested in this trial

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

Treatment groups

93 Participants
are divided into 1 treatment group

Sponsors and collaborators