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Point of Care - Sepsis Study

NCT07774013 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-08-19

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07774013 on ClinicalTrials.gov