Neonate / IL6 / Point-of-Care Measurement of Inflammatory Biomarkers · Observational Study

Point of Care - Sepsis Study

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned observational pilot study registered on ClinicalTrials.gov that will compare point-of-care measurement of inflammatory biomarkers (IL-6, PCT, CRP, MxA) against standard laboratory methods in preterm infants with suspected early infection. No results are reported in this registry record, and the study has not yet begun recruitment.

What was studied

Observational. Neonate, Sepsis, IL6, PCT, Point of Care. Intervention: Preterm infants immediately after birth with suspected infe…. Compared with: Standard laboratory measurement of the same biomarkers.. n = 80. 1 site: Austria.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This study is too early-stage to inform clinical practice. Once results are available, comparison of agreement between point-of-care and laboratory methods may support or refute use of rapid testing in neonatal sepsis screening, but validation in larger cohorts and clinical outcome studies would be needed before adoption.

Plain-language summary

This is an uncontrolled observational pilot study with no results posted; it evaluates agreement between measurement methods in a small sample of neonates, a first step toward clinical validation.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Agreement of IL-6, PCT, and CRP measurements between point-of-care and standard laboratory methods (assessed at At birth and during the first 36 hours of life)

DesignObservational

PopulationNeonate, Sepsis, IL6, PCT, Point of Care

Sample size80

InterventionPreterm infants immediately after birth with suspected infe…

ComparatorStandard laboratory measurement of the same biomarkers.

Setting1 site: Austria

Reported figures

Quoted from the source exactly as published.

Planned sample size40–80

Primary outcome measureAgreement of IL-6, PCT, and CRP measurements between point-of-care and standard laboratory methods, at birth and during the first 36 hours of life

Study phasePilot

Clinical bottom line

Caveats

Registry record only; no results posted; no efficacy, diagnostic accuracy, or clinical outcome data available.
Observational, uncontrolled design limits ability to draw causal conclusions or assess clinical benefit.
Planned sample size (40–80) is small for method validation; power analysis not reported.
Secondary hypotheses regarding early detection and viral vs. bacterial differentiation are exploratory and not powered.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Observational, single-arm, no control group or comparator arm.

Directness

moderate

Measures agreement between point-of-care and laboratory methods; indirect relevance to clinical decision-making.

Consistency

insufficient

Registry record; no results reported; consistency with other evidence cannot be assessed.

Risk of bias

insufficient

Study not yet recruiting; no methods detail sufficient to assess bias risk.

Sample adequacy

limited

Estimated 40–80 preterm infants enrolled; small sample for method validation.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07774013). This is a study registration, not published results. Lead sponsor: Medical University of Graz. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 80 participants (ESTIMATED). Conditions: Neonate, Sepsis, IL6, PCT, Point of Care. Interventions: DEVICE: Point-of-Care Measurement of Inflammatory Biomarkers. Primary outcome measures: Agreement of IL-6, PCT, and CRP measurements between point-of-care and standard laboratory methods , At birth and during the first 36 hours of life. Brief 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.

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Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07774013NeonateIL6Point-of-Care Measurement of Inflammatory BiomarkersSepsisMedical University of Graz