[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601389":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":10,"centralContacts":26,"locations":35,"responsibleParty":50,"collaborators":10,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":78,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Medical University of Graz","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Observational cohort",null,"This cohort includes term and moderate-to-late preterm neonates (birth weight ≥ 2000g) with respiratory distress within the first 6 hours after birth, admitted to the neonatal intensive care unit. All enrolled neonates undergo non-invasive monitoring to assess the predictive value of the POP-Score for identifying elevated CRP (≥20 mg\u002FL) within the first 48 hours after birth. The cohort will also be analyzed to evaluate differences in multi-site NIRS measurements (peripheral muscle, cerebral, intestinal, and flank) between those with and without CRP elevation.",[13,14],"Diagnostic Test: POP-Score Assessment","Device: Near-Infrared Spectroscopy (NIRS)",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"DIAGNOSTIC_TEST","POP-Score Assessment","A non-invasive score calculated within the first 6 hours after birth using peripheral muscle oxygenation (pTOI, measured via near-infrared spectroscopy), heart rate, arterial oxygen saturation (SpO2), systolic blood pressure (SABP), and subcutaneous fat layer thickness. The score is evaluated for its ability to predict C-reactive protein (CRP) levels ≥ 20 mg\u002FL within 48 hours.",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DEVICE","Near-Infrared Spectroscopy (NIRS)","NIRS measurements are performed within 6 hours after birth using the NIRO 200NX device at four anatomical sites (forearm, forehead, infraumbilical region, and left flank). Measurements assess peripheral muscle, cerebral, intestinal, and flank oxygenation to identify possible differences in tissue perfusion associated with early inflammation or infection.",[9],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Christina H. Wolfsberger, MD, PhD","CONTACT","+43 316 385 81135","christina.wolfsberger@medunigraz.at",{"name":33,"role":29,"phone":10,"phoneExt":10,"email":34},"Gerhard Pichler, Prof","gerhard.pichler@medunigraz.at",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":10},"Medical University of Graz, Division of Neonatology","RECRUITING","Graz","Styria","8036","Austria","AT",{"type":45,"coordinates":46},"Point",[47,48],15.44197,47.06733,{"lat":48,"lon":47},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Christina Wolfsberger, MD","Principal Investigator","100601389","the-peripheral-muscle-oxygenation-and-perfusion-score-as-a-new-non-invasive-tool-to-predict-elevations-in-c-reactive-protein-levels-in-neonates-100601389",false,"NCT07109856","The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates","The Peripheral(-Muscle) Oxygenation and Perfusion Score (POPScore) a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates - a Prospective Phase II Observational Study","POP-Score","Inclusion Criteria:\n\n* birth weight ≥ 2000 grams\n* Signs of respiratory distress at time-point of inclusion (tachypnoea \\>60\u002Fmin, grunting, intercostal\u002Fsubcostal\u002Fjugular retractions, nasal flaring, supplemental oxygen or respiratory support)\n* Decision to conduct full life support\n* Written informed consent obtained within the first 6 hours after birth, before inclusion in the study\n* Age \\\u003C 6 hours\n\nExclusion Criteria:\n\n* No decision to conduct full life support\n* No written informed consent\n* Birth weight \\\u003C 2000 grams\n* Age \\> 6 hours\n* Severe congenital malformations,\n* Umbilical cord artery pH \\\u003C7.20","ALL","0 Hours","6 Hours",{"count":66,"type":67},93,"ESTIMATED","OBSERVATIONAL","This is a prospective, single-center Phase II observational study investigating the predictive value of the \"Peripheral(-muscle) Oxygenation and Perfusion Score\" (POP-Score), a novel non-invasive composite index, for early detection of infection\u002Finflammation in neonates. The POP-Score combines peripheral muscle oxygenation measured via near-infrared spectroscopy (NIRS) with routinely monitored clinical parameters (heart rate, oxygen saturation, systolic blood pressure, and subcutaneous fat thickness). The study aims to determine the optimal cut-off value of the POP-Score measured within the first 6 hours after birth to predict elevated C-reactive protein (CRP ≥20 mg\u002FL) within 48 hours. Additionally, multi-site NIRS measurements (cerebral, peripheral muscle, intestinal, and flank) will be evaluated to assess their association with inflammation. The study includes term and moderate-to-late preterm neonates (birth weight ≥2000g) with respiratory distress, admitted to the neonatal intensive care unit at the Medical University of Graz.",[71,72,73,74,75,76,77],"Prematurity, Infections","NIRS","Near Infrared Spectroscopy","Preterm Neonates","Term Infant","Infection","Neonatal Sepsis, Early-Onset",[72,79,60,80,81],"near-infrared spectroscopy","neonates","preterm neonates","2026-05-12",{"date":84,"type":85},"2026-05-14","ACTUAL",{"date":87,"type":85},"2025-11-27",{"date":89,"type":67},"2028-05-01",{"name":5,"class":6},1]