[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656001":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":19,"interventions":29,"overallOfficials":13,"centralContacts":35,"locations":41,"responsibleParty":58,"collaborators":13,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":13,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":13,"studyType":74,"phases":13,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":44,"whyStopped":13,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Tanta University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Diagnostic Performance of Monocyte Distribution Width for Late-Onset Neonatal Sepsis","Monocyte distribution width (MDW) will be measured as part of the complete blood count at the time of first clinical suspicion of late-onset neonatal sepsis. Its diagnostic performance for culture-proven late-onset neonatal sepsis will be evaluated using receiver operating characteristic (ROC) curve analysis, including area under the curve (AUC), optimal cutoff value, sensitivity, specificity, positive predictive value, and negative predictive value.","At enrollment, with reference classification based on blood culture results available within approximately 5 days",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","Neonatal sepsis is a major cause of morbidity and mortality among newborns worldwide. It represents a systemic inflammatory response to infection that can rapidly progress to severe complications, including multi-organ dysfunction and death. The clinical presentation is often nonspecific, making early diagnosis challenging and frequently delayed. The diagnosis of LOS relies on a combination of clinical suspicion, microbiological confirmation, and supportive laboratory findings. Blood culture remains the gold standard for diagnosis, as it confirms the infection and identifies the causative organism, allowing for targeted antibiotic therapy. Biomarkers play an essential role in the early detection and management of sepsis. Commonly used biomarkers include C-reactive protein (CRP), an indicator of systemic inflammation and infection. However, these markers have limitations, including delayed elevation, lack of specificity, and variability in sensitivity, especially in neonatal populations. Additional diagnostic tools such as molecular assays (e.g., polymerase chain reaction techniques) have improved the speed of pathogen identification but are not yet universally available. Monocyte distribution width (MDW) is a novel hematological parameter that reflects changes in monocyte size and morphology during inflammatory processes. Monocytes are among the first immune cells to respond to infection, undergoing functional and structural alterations that can be quantitatively assessed through MDW.","A total of 60 preterm neonates with clinical suspicion of late-onset neonatal sepsis (LONS) will be included. All eligible neonates admitted to the Neonatal Intensive Care Unit (NICU) of the Pediatrics Department, Tanta University Hospitals, will be screened, and those meeting the inclusion criteria will be enrolled consecutively at the time of first clinical suspicion of sepsis",[20,25],{"label":21,"type":13,"description":22,"interventionNames":23},"Sepsis group","This group will include 30 preterm neonates with suspected LONS who fulfill the predefined clinical and laboratory criteria of clinical sepsis and\u002For have positive blood culture",[24],"Diagnostic Test: MDW measurement",{"label":26,"type":13,"description":27,"interventionNames":28},"Control group","It will include 30 neonates evaluated for suspected sepsis who will have negative blood cultures, will not fulfill the predefined clinical sepsis criteria, and will have an alternative non-infectious diagnosis.",[24],[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":13},"DIAGNOSTIC_TEST","MDW measurement","Monocyte Distribution Width (MDW), which represents the standard deviation of monocyte cell volume, will be measured at the time of first clinical suspicion of LONS, preferably before the initiation of antibiotic therapy when possible, using 2 mL peripheral venous blood collected in EDTA tubes. Blood samples will be analyzed as soon as possible after collection using an automated hematology analyzer that reports MDW. The result will be recorded as part of the CBC without requiring an additional blood sample.",[26,21],[36],{"name":37,"role":38,"phone":39,"phoneExt":13,"email":40},"Lamiaa Khaled Zidan","CONTACT","00201007958439","lamia.kh.z@gmail.com",[42],{"facility":43,"status":44,"city":45,"state":13,"zip":13,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Faculty of Medicine, Tanta University","RECRUITING","Tanta","Egypt","EG",{"type":49,"coordinates":50},"Point",[51,52],31.00192,30.78847,{"lat":52,"lon":51},[55],{"name":43,"role":38,"phone":56,"phoneExt":13,"email":57},"2+ 040 3337544","dean@med.tanta.edu.eg",{"type":59,"investigatorFullName":37,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Lecturer of Pediatrics","100656001","mdw-as-a-novel-diagnostic-biomarker-in-lons-among-preterm-neonates-100656001",false,"NCT07821190","MDW as a Novel Diagnostic Biomarker in LONS Among Preterm Neonates","Monocyte Distribution Width as a Novel Diagnostic Biomarker in Late-Onset Sepsis Among Preterm Neonates","Inclusion Criteria:The study will include:\n\n1. Preterm neonates with gestational age \\\u003C37 weeks.\n2. Neonates aged \\>72 hours of life at the time of enrollment.\n3. Neonates with clinical suspicion of late-onset neonatal sepsis, defined by the presence of one or more of the following:\n\n   * Temperature instability (core temperature \\>38°C or \\\u003C36°C)\n   * Respiratory distress or new-onset apnea\n   * Feeding intolerance or poor feeding\n   * Lethargy or irritability\n   * Bradycardia or tachycardia\n   * Hypotension\n   * Unexplained clinical deterioration\n\nExclusion Criteria:\n\n* Neonates with any of the following will be excluded from the study:\n\n  1. Early onset neonatal sepsis.\n  2. Major congenital anomalies\n  3. Chromosomal abnormalities\n  4. Metabolic disorders\n  5. Severe perinatal asphyxia\n  6. Neonates with surgical conditions","ALL","73 Hours","28 Days",{"count":72,"type":73},60,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate the diagnostic accuracy of monocyte distribution width (MDW) as a novel biomarker for late-onset neonatal sepsis in preterm neonates and to assess its association with disease severity and short-term clinical outcomes",[77],"Late Onset Neonatal Sepsis",[79,80],"MDW","LONS","2026-09-09",{"date":83,"type":84},"2026-09-15","ACTUAL",{"date":86,"type":84},"2026-07-01",{"date":88,"type":73},"2027-07-30",{"name":5,"class":6},1]