Point of Care - Sepsis Study

Sponsor
Medical University of Graz
Study ID
NCT07774013
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • IL6
  • Neonate
  • PCT
  • Point of Care
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Point-of-Care Measurement of Inflammatory Biomarkers — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Aug 15, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Preterm infants immediately after birth with suspected infection
    Preterm infants born at less than 37 weeks of gestation who are admitted to the neonatal care unit and have a clinical suspicion of infection will be enrolled. Participants will receive standard clinical care according to institutional protocols. As part of the study, inflammatory markers (IL-6, PCT, CRP, and MxA) will be measured using a point-of-care device. Selected measurements will be compared with standard laboratory measurements. Cord blood will be used for IL-6 and PCT measurements at birth. When heel blood is obtained for routine clinical testing, additional point-of-care measurements may be performed during the first 36 hours of life. The point-of-care test results will not be used to guide clinical treatment or patient management. Clinical decisions, including antibiotic treatment and additional diagnostic testing, will be based on standard-of-care assessments.

Primary Outcome Measure

Agreement of IL-6, PCT, and CRP measurements between point-of-care and standard laboratory methods [ Time Frame: At birth and during the first 36 hours of life ]

Central Contacts

Related Studies