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

Not yet recruitingOBSERVATIONAL
Enrollment

93

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

March 1, 2028

Study Completion Date

May 1, 2028

Conditions
Prematurity, InfectionsNIRSNear Infrared SpectroscopyPreterm NeonatesTerm InfantInfectionNeonatal Sepsis, Early-Onset
Interventions
DIAGNOSTIC_TEST

POP-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.

DEVICE

Near-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.

Trial Locations (1)

8036

Medical University of Graz, Division of Neonatology, Graz

All Listed Sponsors
lead

Medical University of Graz

OTHER

NCT07109856 - The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates | Biotech Hunter | Biotech Hunter