[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647345":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":41,"studyPopulation":33,"armGroups":42,"interventions":53,"overallOfficials":62,"centralContacts":67,"locations":77,"responsibleParty":98,"collaborators":33,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":33,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":80,"whyStopped":33,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Menoufia University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Favorable functional outcome defined as modified Rankin Scale (mRS) score ≤ 2. The mRS will be assessed by a blinded assessor.","Modified Rankin Scale (mRS) score:\n\nScore Description Pediatric Adaptation 0 No symptoms. Age-appropriate functioning in all areas (motor, cognition, behavior).\n\n1. No significant disability; able to carry out all usual activities despite symptoms. Mild behavioral or school-related issues but independent in daily activities.\n2. Slight disability; unable to perform all previous activities but independent in self-care. Minor delays in school or play; needs extra time but no assistance in self-care.\n3. Moderate disability; requires some help but can walk unassisted. Requires assistance in daily activities (feeding, dressing) but ambulant.\n4. Moderately severe disability; unable to walk or attend to bodily needs without help. Dependent for most activities; may be wheelchair-bound but responsive.\n5. Severe disability; bedridden, incontinent, requires constant nursing care. Completely dependent; may have profound cognitive or motor impairment.\n6. Death. Death.","Within 24 hours after completion of the final plasma exchange session.",[14,18,22,26,30],{"measure":15,"description":16,"timeFrame":17},"Time to clinical improvement","Time from randomization to the first sustained improvement of at least one point on the modified Rankin Scale (mRS), maintained for at least 48 hours.","Up to 90 days after randomization",{"measure":19,"description":20,"timeFrame":21},"Length of stay in the intensive care unit","Duration of stay in the pediatric intensive care unit, measured in days from ICU admission until ICU discharge.","Through ICU discharge (up to 90 days)",{"measure":23,"description":24,"timeFrame":25},"Total hospital length of stay","Duration of hospitalization, measured in days from hospital admission until hospital discharge.","Through hospital discharge (up to 90 days)",{"measure":27,"description":28,"timeFrame":29},"Incidence of plasma exchange-related adverse events","Number of participants experiencing plasma exchange-related adverse events, including hypotension, citrate toxicity, bleeding, catheter-related infection, catheter malfunction, allergic reactions, or transfusion reactions.","From the first plasma exchange session until 7 days after the final plasma exchange session",{"measure":31,"description":32,"timeFrame":17},"All-cause mortality","Death from any cause during the study follow-up period.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"RANDOMIZED","PARALLEL","The study population will be divided into two groups( two arms) , the first group will perform PLEX on consecutive days and the second one will perform it every other day.","TREATMENT",{"masking":40,"maskingDescription":33,"whoMasked":33},"NONE","This will be a Prospective, randomized, open- label, parallel-group, center trial, which will include enough number of children admitted at Pediatric Intensive Care Unit (PICU) of Menoufia university Hospital with autoimmune encephalitis from August 2026 to February 2027.\n\nGrouping :\n\nThe study population will be divided into two groups:\n\n1. Daily PLEX Group (Arm A):\n\n   This group will perform PLEX on consecutive days (e.g., Day 1, 2, 3, 4, 5) for 5 sessions; up to 7 sessions allowed.\n2. Alternate-Day PLEX Group (Arm B):\n\nThis group will perform PLEX every other day (e.g., Day 1, 3, 5, 7, 9) for 5 sessions; up to 7 sessions allowed.\n\nAll patients in this study will be subjected to:\n\nA- Demographic and clinical data Collection:\n\n* Patient demographics: age, sex, Wt., Ht., and body mass index (BMI).\n* PLEX parameters: date\u002Ftime of each session, exchanged volume, replacement fluid, anticoagulation used and immediate complications if any.\n\nB- Full clinical examination will be done including vital signs (HR, RR, BP, temperature), Pediatric Glasgow Coma Scale to assess consciousness level and neurological examination.\n\nC- Investigations will be done including the following:\n\nLaboratory Analysis: CBC, CRP, Electrolytes, calcium level, blood culture, urea, creatinine, ALT, AST, procalcitonin, coagulation profile and D-dimer level.\n\nRadiological: Chest X ray, Brain CT, MRI and EEG if they needed. Intervention and Monitoring\n\nPlasma Exchange Procedure (both arms):\n\nA- Access: Central venous catheter (size appropriate for age and weight) or existing dialysis catheter.\n\nB- Exchange volume: 1-1.5 plasma volumes per session (age\u002Fweight-adjusted - typical formula: plasma volume = 0.07 × weight in kg × (1 - hematocrit)).\n\nC- Replacement fluid: 5% human albumin as first choice; fresh frozen plasma (FFP) may be used if clinically indicated (bleeding, coagulopathy), or combination as per local protocol.\n\nD- Anticoagulation: Regional citrate anticoagulation or systemic heparin according to institutional practice; monitor ionized calcium if citrate used.\n\nE- Monitoring: Vital signs pre-, intra-, and post-procedure; electrolytes, coagulation profile and calcium level as clinically indicated.\n\nF- Number of sessions: Up to 5 sessions recommended; clinicians may extend to 7 sessions if inadequate clinical response.",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"Arm A: Daily PLEX Group","ACTIVE_COMPARATOR","This group (Arm A) will perform PLEX on consecutive days (e.g., Day 1, 2, 3, 4, 5) for 5 sessions; up to 7 sessions allowed.\n\nIntervention for Arm A:\n\nPlasma Exchange Procedure :\n\nA- Access: Central venous catheter (size appropriate for age and weight) or existing dialysis catheter.\n\nB- Exchange volume: 1-1.5 plasma volumes per session (age\u002Fweight-adjusted - typical formula: plasma volume = 0.07 × weight in kg × (1 - hematocrit)).\n\nC- Replacement fluid: 5% human albumin as first choice; fresh frozen plasma (FFP) may be used if clinically indicated (bleeding, coagulopathy), or combination as per local protocol.\n\nD- Anticoagulation: Regional citrate anticoagulation or systemic heparin according to institutional practice; monitor ionized calcium if citrate used.\n\nE- Monitoring: Vital signs pre-, intra-, and post-procedure; electrolytes, coagulation profile and calcium level as clinically indicated.",[48],"Procedure: Plasma exchange (PE)",{"label":50,"type":45,"description":51,"interventionNames":52},"Arm B : Alternate-Day PLEX Group","This group ( Arm B) will perform PLEX every other day (e.g., Day 1, 3, 5, 7, 9) for 5 sessions; up to 7 sessions allowed.",[48],[54,59],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":33},"PROCEDURE","Plasma exchange (PE)","Plasma exchange (PE) sessions to be done daily for Arm A",[44,50],{"type":55,"name":56,"description":60,"armGroupLabels":61,"otherNames":33},"Plasma exchange (PE) sessions to be done on every other day for Arm B",[44,50],[63],{"name":64,"affiliation":65,"role":66},"Hani Hamed Saad, MD, lecturer of pediatrics","Faculty of medicine, Menoufia University","PRINCIPAL_INVESTIGATOR",[68,73],{"name":69,"role":70,"phone":71,"phoneExt":33,"email":72},"Hani Hamed Saad, MD, pediatrics","CONTACT","+201067610619","hani.hamed870@med.menofia.edu.eg",{"name":74,"role":70,"phone":75,"phoneExt":33,"email":76},"Nagwan Yossery Saleh, MD, Pediatrics","+201003961071","drnagwan80@gmail.com",[78],{"facility":79,"status":80,"city":81,"state":82,"zip":33,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Menoufia university hospital, Pediatric intensive care unit","RECRUITING","Shibīn al Kawm","Menoufia Governorate","Egypt","EG",{"type":86,"coordinates":87},"Point",[88,89],31.00904,30.55258,{"lat":89,"lon":88},[92,93,96],{"name":64,"role":66,"phone":33,"phoneExt":33,"email":33},{"name":94,"role":95,"phone":33,"phoneExt":33,"email":33},"Nagwan Yossery Saleh, MD, pediatrics","SUB_INVESTIGATOR",{"name":97,"role":95,"phone":33,"phoneExt":33,"email":33},"Amira Zaki Badawy, MD, clinical pathology",{"type":66,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Hani Hamed Saad","lecturer of pediatrics at Faculty of medicine , Menoufia university","100647345","plasma-exchange-in-pediatric-autoimmune-encephalitis-100647345",false,"NCT07707739","Plasma Exchange in Pediatric Autoimmune Encephalitis","Daily Versus Alternate-Day Plasma Exchange in Pediatric Autoimmune Encephalitis: A Randomized Controlled Trial","PE\u002FAIE","Inclusion Criteria:\n\n* Childern diagnosed as autoimmune encephalitis according to Cellucci et al., 2020; acute\u002Fsubacute onset (\\\u003C3 months) of encephalopathy with at least one of: new focal CNS findings, seizures, CSF pleocytosis, MRI suggestive of encephalitis, and supportive antibody testing when available.\n* Autoimmune encephalitis cases indicated clinically for PLEX as determined by the treating team (e.g., severe disease, refractory to steroids\u002FIVIG or as part of first-line combination therapy).\n\nExclusion Criteria:\n\n* Hemodynamic instability not amenable to plasma exchange.\n* Severe coagulopathy uncorrectable prior to PLEX (INR \\>2 despite correction, platelets \\\u003C50,000\u002FµL unless corrected).\n* Contraindications to central venous access placement.\n* Enrollment in another interventional trial that would interfere with the outcomes.","ALL","1 Month","18 Years",{"count":113,"type":114},22,"ESTIMATED","INTERVENTIONAL",[117],"NA","The aim of the study will be to compare the efficacy of daily plasma exchange (PLEX) versus alternate-day PLEX in achieving a favorable functional outcome in children with autoimmune encephalitis.\n\nThe study population will be divided into two groups, the first group will perform PLEX on consecutive days and the second one will perform it every other day. Then, A Favorable functional outcome measure defined as modified Rankin Scale (mRS) score ≤ 2. The mRS will be assessed by a blinded assessor at the end of the sessions to determine which method has superior efficacy in treatment of autoimmune encephalitis.",[120],"Autoimmune Encephalitis (AE)",[122,123,124,125],"Plasma Exchange","Autoimmune Encephalitis","Pediatric","Randomized Controlled Trial","2026-08-21",{"date":128,"type":129},"2026-08-24","ACTUAL",{"date":131,"type":114},"2026-08-01",{"date":133,"type":114},"2027-03-31",{"name":5,"class":6},1]