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Point of Care - Sepsis Study
Sponsor: Medical University of Graz
Summary
This pilot study will evaluate whether a rapid point-of-care blood test can help identify early signs of infection and sepsis in preterm infants. The study will include preterm infants born before 37 weeks of pregnancy who are admitted to the neonatal care unit and have a suspected infection. The researchers will measure several substances in the blood that can increase during infection, including interleukin-6 (IL-6), procalcitonin (PCT), C-reactive protein (CRP), and myxovirus resistance protein A (MxA). Results obtained with the point-of-care device will be compared with standard laboratory measurements. The researchers will also study whether measuring IL-6 and PCT during the first 12 hours of life may provide useful information about infection earlier than CRP testing and whether combined MxA and CRP measurements may help distinguish bacterial from viral infections. This is an observational study and will not change the infants' standard medical care or treatment. Results from the point-of-care device will not be used to make treatment decisions during the study. Blood samples will be collected as part of, or together with, routine blood sampling whenever possible. The study is expected to include approximately 40 preterm infants, with a maximum of 80 infants enrolled.
Official title: Diagnostic Accuracy of Inflammatory Parameters for the Diagnosis of Early Onset Neonatal Sepsis and Differentiation Between Viral and Bacterial Infections in Preterm Infants Using a Point-of-care Device - a Pilot Study (POCT Sepsis)
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
80
Start Date
2026-08-13
Completion Date
2028-08-31
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
Point-of-Care Measurement of Inflammatory Biomarkers
Inflammatory biomarkers are measured using the AFIAS-3 point-of-care device. IL-6 and PCT are measured in cord blood at birth and may also be measured in neonatal heel blood during the first 12 hours of life when blood is obtained for routine blood gas analysis. CRP is measured using the point-of-care device at the time of routine CRP testing and compared with standard laboratory measurements. A combined MxA/CRP point-of-care measurement is also performed to explore its potential for differentiating bacterial from viral infections. Point-of-care results are collected for study purposes and are not used for clinical decision-making or patient management.
Locations (1)
Medical University Graz
Graz, Styria, Austria