[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prematurity-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prematurity-infections":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"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":21,"type":22},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.",[26,27,28,29,30,31,32],"Prematurity, Infections","NIRS","Near Infrared Spectroscopy","Preterm Neonates","Term Infant","Infection","Neonatal Sepsis, Early-Onset",[27,34,15,35,36],"near-infrared spectroscopy","neonates","preterm neonates","RECRUITING","2026-05-12",{"date":40,"type":41},"2026-05-14","ACTUAL",{"date":43,"type":41},"2025-11-27",{"date":45,"type":22},"2028-05-01",{"name":47,"class":48},"Medical University of Graz","OTHER"]