[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644464":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":12,"collaborators":10,"id":16,"slug":17,"hasResults":18,"nctId":19,"briefTitle":20,"officialTitle":21,"acronym":10,"eligibilityCriteria":22,"healthyVolunteers":18,"sex":23,"minAge":24,"maxAge":25,"enrollmentInfo":26,"targetDuration":10,"studyType":29,"phases":10,"briefSummary":30,"conditions":31,"keywords":34,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":10},{"fullName":5,"class":6},"Assiut University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Neonates with Suspected Sepsis",null,"This cohort includes term and preterm neonates aged 0 to 28 days admitted to the Neonatal Intensive Care Unit (NICU) presenting with two or more clinical signs highly suggestive of sepsis (e.g., temperature instability, tachycardia\u002Fbradycardia, tachypnea, feeding intolerance, lethargy, or altered muscle tone). Upon admission and prior to the administration of any empirical antimicrobial therapy, peripheral venous blood samples will be drawn to evaluate Complete Blood Count (CBC) indices, quantify serum lactate levels, and perform a blood culture. As this is an observational study, no experimental interventions or medications will be administered to this group.",{"type":13,"investigatorFullName":14,"investigatorTitle":15,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Faten Samir Malak Nashed","Resident at Pediatric Department, Assiut University","100644464","cbc-indices-and-serum-lactate-in-neonatal-sepsis-100644464",false,"NCT07663084","CBC Indices and Serum Lactate in Neonatal Sepsis","Diagnostic and Prognostic Values of CBC Indices and Serum Lactate in Neonatal Sepsis","Inclusion Criteria:\n\n* Neonates aged 0 to 28 days (term and preterm).\n* Presence of two or more clinical signs highly suggestive of sepsis (e.g., temperature instability \\[\\\u003C 36.5°C or \\> 37.5°C\\], tachycardia\u002Fbradycardia, tachypnea, feeding intolerance, lethargy, or altered muscle tone).\n* Informed written consent obtained from the parents or legal guardians.\n\nExclusion Criteria:\n\n* Neonates with severe congenital anomalies or chromosomal abnormalities.\n* Neonates diagnosed with Inborn Errors of Metabolism (which inherently alter lactate levels).\n* Neonates with severe perinatal asphyxia or Hypoxic-Ischemic Encephalopathy (HIE), as these conditions cause profound primary lactic acidosis independent of sepsis.\n* Neonates who received prior broad-spectrum intravenous antibiotics for more than 24 hours prior to admission.\n* Neonates who have received prior blood transfusions.\n* Neonates requiring immediate surgical intervention.","ALL","0 Days","28 Days",{"count":27,"type":28},80,"ESTIMATED","OBSERVATIONAL","Neonatal sepsis is a leading cause of illness and death in Neonatal Intensive Care Units (NICUs). Diagnosing it quickly is challenging because the early signs often overlap with other common newborn health issues. While a blood culture is the most accurate way to confirm an infection, the results can take 48 to 72 hours. This delay highlights the need for faster, more accessible diagnostic tools.\n\nThis observational study aims to find quicker ways to diagnose neonatal sepsis and predict its severity using readily available blood tests. Researchers are investigating whether specific details from a standard Complete Blood Count (CBC), such as the variation in red blood cell size (RDW), the average size of platelets (MPV), and the ratio of immature to total white blood cells (I\u002FT ratio), combined with serum lactate levels (a marker of tissue oxygenation and stress) can serve as reliable, early warning signs.\n\nThe study will enroll newborns (0 to 28 days old) admitted to the NICU who show clinical signs of a possible infection. Upon admission and before starting any antibiotic treatment, a small blood sample will be drawn to measure these CBC indices and serum lactate, alongside the standard blood culture.\n\nBy comparing these rapid blood test results with the final blood culture outcomes and the infants' overall clinical progress in the NICU, the research team hopes to determine if this simple combination of markers can help doctors diagnose sepsis earlier, anticipate the severity of the illness, and make faster, life-saving treatment decisions.",[32,33],"Neonatal Sepsis","Sepsis",[32,35,36,37,38,39,40,41],"Complete Blood Count Indices","Serum Lactate","Mean Platelet Volume","Immature-to-Total Neutrophil Ratio","Red Cell Distribution Width","Diagnostic Biomarkers","Prognosis","NOT_YET_RECRUITING","2026-06-17",{"date":45,"type":46},"2026-06-23","ACTUAL",{"date":48,"type":28},"2026-08",{"date":50,"type":28},"2027-09",{"name":5,"class":6}]