[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652456":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":29,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":10,"maxAge":10,"enrollmentInfo":59,"targetDuration":10,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":70,"overallStatus":74,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Medical University of Graz","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Preterm infants immediately after birth with suspected infection",null,"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.\n\nAs 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.\n\nThe 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.",[13],"Device: Point-of-Care Measurement of Inflammatory Biomarkers",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Point-of-Care Measurement of Inflammatory Biomarkers","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\u002FCRP 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.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Nariae Baik-Schneditz, MD,PhD","CONTACT","+436644655371","nariae.baik@medunigraz.at",{"name":27,"role":23,"phone":10,"phoneExt":10,"email":28},"Bernhard Schwaberger, MD., PhD.","bernhard.schwaberger@medunigraz.at",[30],{"facility":31,"status":10,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Medical University Graz","Graz","Styria","8034","Austria","AT",{"type":38,"coordinates":39},"Point",[40,41],15.44197,47.06733,{"lat":41,"lon":40},[44],{"name":45,"role":23,"phone":46,"phoneExt":10,"email":47},"Gerhard Pichler, Prof.","+43 316 385 80520","gerhard.pichler@medunigraz.at",{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100652456","point-of-care---sepsis-study-100652456",false,"NCT07774013","Point of Care - Sepsis Study","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)","POCT Sepsis","Inclusion Criteria:\n\n* Preterm neonates born at \\\u003C37+0 weeks of gestation who are admitted to the Division of Neonatology, Department of Pediatrics, Medical University of Graz after birth.\n* Written parental informed consent before birth.\n\nExclusion Criteria:\n\n* Term and preterm neonates who are not admitted to the neonatal care unit.\n* 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.","ALL",{"count":60,"type":61},80,"ESTIMATED","OBSERVATIONAL","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.\n\nThe 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.\n\nThis 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.",[65,66,67,68,69],"Neonate","Sepsis","IL6","PCT","Point of Care",[71,72,67,68,73],"neonate","sepsis","Point of care","NOT_YET_RECRUITING","2026-08-12",{"date":77,"type":78},"2026-08-19","ACTUAL",{"date":80,"type":61},"2026-08-15",{"date":82,"type":61},"2028-08-31",{"name":5,"class":6},1]