Clinical trial Recruiting at 1 site Observational

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.

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Quick facts

Study typeObservational
SexAll
Enrollment80 (estimated)
SponsorMedical University of Graz
Academic / other
Locations1 site (Graz, Styria)
StatusRecruiting
StartedAugust 13, 2026
Main results expectedAugust 31, 2028
Study endsAugust 31, 2028
Registry record updatedOctober 6, 2026
Trial IDNCT07774013 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.