Point of Care - Sepsis Study

NCT07774013 | Not Yet Recruiting DMC

• 1 other identifier: 1361/2025
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonate; Sepsis; IL6; PCT; Point of Care

Keywords

neonate; sepsis; IL6; PCT; Point of care

Outcome Measures

Primary Outcomes (1)

• Agreement of IL-6, PCT, and CRP measurements between point-of-care and standard laboratory methods

  Quantitative IL-6 and PCT levels in cord blood and CRP levels in neonatal blood will be measured using both the point-of-care device and standard laboratory methods to assess correlation between the two measurement methods.

  At birth and during the first 36 hours of life

Secondary Outcomes (1)

• Early IL-6 and PCT levels in neonatal blood

  At birth and during the first 36 hours of life

Other Outcomes (1)

• Combined MxA/CRP measurement

  At birth and during the first 36 hours of life

Study Arms (1)

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.

Device: Point-of-Care Measurement of Inflammatory Biomarkers

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.

Preterm infants immediately after birth with suspected infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of preterm neonates born at less than 37+0 weeks of gestation who are admitted to the Division of Neonatology, Department of Pediatrics, Medical University of Graz after birth and have a clinical suspicion of infection. Eligible infants are enrolled prospectively before their sepsis status is established. Participants are subsequently classified into an infection/sepsis group or a control group according to predefined diagnostic criteria. Approximately 40 preterm neonates are expected to be included, with an overall maximum of 80 participants.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz

Graz, Styria, 8034, Austria

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nariae Baik-Schneditz, MD,PhD

CONTACT

+436644655371; nariae.baik@medunigraz.at

Bernhard Schwaberger, MD., PhD.

CONTACT

bernhard.schwaberger@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 19, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08

Locations

AU (1)