Point of Care - Sepsis Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMedical University of Graz

About this trial

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.

Eligibility criteria

Qualifiers

Preterm neonates born at <37+0 weeks of gestation who are admitted to the Division of Neonatology, Department of Pediatrics, Medical University of Graz after birth.

Written parental informed consent before birth.

Disqualifiers

Term and preterm neonates who are not admitted to the neonatal care unit.

No point-of-care measurement of IL-6 and PCT in neonatal blood for infants who do not require blood gas analysis within the first 12 hours of life.

Trial design

Treatments tested in this trial

  • Point-of-Care Measurement of Inflammatory Biomarkers

Treatment groups

80 Participants
are divided into 1 treatment group

Sponsors and collaborators