Point of Care - Sepsis Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMedical University of Graz
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Point-of-Care Measurement of Inflammatory Biomarkers
DeviceInflammatory 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Preterm infants immediately after birth with suspected infection1 intervention
Trial outcomes
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.
Time frame
At birth and during the first 36 hours of lifeSecondary outcomes
1
Early IL-6 and PCT levels in neonatal blood
IL-6 and PCT levels will be measured using the point-of-care device in heel blood obtained during routine blood sampling within the first 12 hours of life, before routine CRP measurement is available.
Time frame
At birth and during the first 36 hours of lifeOther outcomes
1
Combined MxA/CRP measurement
MxA and CRP will be measured using a combined point-of-care test at the time of the first routine CRP measurement to explore the potential of MxA/CRP testing for differentiating bacterial from viral infection.
Time frame
At birth and during the first 36 hours of lifeSponsors and contacts
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Source ClinicalTrials.gov