Point-of-Care Test for Early Infection Signs in Preterm Babies
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)
Run by Medical University of Graz · NCT07774013 · Data updated 2026-11-12
This pilot observational study will see if a rapid point-of-care blood test can help detect early signs of infection in preterm infants and compare its results with standard lab tests.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz, Styria) |
| Status | Recruiting |
| Started | August 13, 2026 |
| Main results expected | August 31, 2028 |
| Study ends | August 31, 2028 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT07774013 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Preterm neonates born before 37 weeks gestation admitted to the Graz NICU, with parental consent obtained prenatally.
✕Probably not a fit
Findings may not translate into clinical benefit for all infants and some measurements may not align with standard laboratory results.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, observational pilot evaluates a point-of-care device that measures inflammatory biomarkers in preterm neonates with suspected infection. It compares cord blood IL-6 and PCT, as well as heel-prick CRP, between the point-of-care measurements and conventional laboratory assays. The goal is to determine agreement between methods and to explore whether early IL-6, PCT, and combined MxA/CRP testing can distinguish bacterial from viral infections. The study does not alter standard clinical care. Enrollment targets preterm neonates (<37 weeks) admitted to the Graz NICU with parental consent obtained before birth.
Why it matters
Potential benefit: If successful, rapid point-of-care testing could speed infection detection and facilitate earlier clinical decision-making for preterm babies.
How similar studies have gone: Previous studies in neonatal biomarker testing have shown variable agreement between point-of-care and lab measurements; this study adds data on IL-6, PCT, CRP, and MxA.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where it's running
-
Medical University Graz
Graz, Styria, Austria Recruiting
Study contacts
- Study coordinator: Nariae Baik-Schneditz, MD,PhD
- Email: nariae.baik@medunigraz.at
- Phone: +436644655371
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.