Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-02 @ 8:33 AM
Study NCT ID:
NCT05853159
Status:
UNKNOWN
Last Update Posted:
2023-05-10
First Post:
2023-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Radiological Prognostic Factors of Acute Necrotizing Encephalopathy in Sohag University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-02-07', 'releaseDate': '2025-01-14'}], 'estimatedResultsFirstSubmitDate': '2025-01-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004684', 'term': 'Leukoencephalitis, Acute Hemorrhagic'}], 'ancestors': [{'id': 'D004673', 'term': 'Encephalomyelitis, Acute Disseminated'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-07', 'studyFirstSubmitDate': '2023-04-19', 'studyFirstSubmitQcDate': '2023-05-07', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute necrotizing encephalitis severity score', 'timeFrame': 'one year', 'description': 'Clinical and Radiological Prognostic Factors of Acute Necrotizing Encephalopathy in Sohag University Hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Necrotizing Encephalopathy']}, 'referencesModule': {'references': [{'pmid': '33163461', 'type': 'BACKGROUND', 'citation': 'Bashiri FA, Al Johani S, Hamad MH, Kentab AY, Alwadei AH, Hundallah K, Hasan HH, Alshuaibi W, Jad L, Alrifai MT, Hudairi A, Al Sheikh R, Alenizi A, Alharthi NA, Abdelmagid TA, Ba-Armah D, Salih MA, Tabarki B. Acute Necrotizing Encephalopathy of Childhood: A Multicenter Experience in Saudi Arabia. Front Pediatr. 2020 Oct 9;8:526. doi: 10.3389/fped.2020.00526. eCollection 2020.'}, {'pmid': '32426208', 'type': 'BACKGROUND', 'citation': 'Levine JM, Ahsan N, Ho E, Santoro JD. Genetic Acute Necrotizing Encephalopathy Associated with RANBP2: Clinical and Therapeutic Implications in Pediatrics. Mult Scler Relat Disord. 2020 Aug;43:102194. doi: 10.1016/j.msard.2020.102194. Epub 2020 May 15.'}, {'pmid': '35688614', 'type': 'BACKGROUND', 'citation': 'Wu L, Peng H, Jiang Y, He L, Jiang L, Hu Y. Clinical features and imaging manifestations of acute necrotizing encephalopathy in children. Int J Dev Neurosci. 2022 Aug;82(5):447-457. doi: 10.1002/jdn.10201. Epub 2022 Jun 22.'}, {'pmid': '33388740', 'type': 'BACKGROUND', 'citation': 'Song Y, Li S, Xiao W, Shen J, Ma W, Wang Q, Yang H, Liu G, Hong Y, Li P, Yang S. Influenza-Associated Encephalopathy and Acute Necrotizing Encephalopathy in Children: A Retrospective Single-Center Study. Med Sci Monit. 2021 Jan 3;27:e928374. doi: 10.12659/MSM.928374.'}]}, 'descriptionModule': {'briefSummary': 'Acute necrotizing encephalopathy of childhood (ANEC) is a fulminant type of encephalopathy. Most reported cases occur in Asian children with the highest prevalence among patients between the age of 6 and 18 months. The most common clinical presentations are fever, rapid alteration in the level of consciousness, and seizures, in addition to characteristic findings in brain imaging that include, but are not limited to, bilateral thalamic lesions with supra and infra-tentorial lesions of variable dimensions.\n\nThe diagnosis of ANEC was determined by specific diagnostic criteria as described by Mizuguchi \\[1\\] which consist of\n\n1. Encephalopathy preceded by viral febrile illness with rapid deterioration in the level of consciousness and convulsions.\n2. Absent cerebrospinal fluid (CSF) pleocytosis.\n3. Symmetric multifocal brain lesions.\n4. Elevation in serum aminotransferase levels.\n5. Exclusion of similar diseases. The ANE severity score was used to assess the severity of illness after admission for shock (3 points), brainstem lesions (2 points), age \\>4 years (2 points), platelet (PLT) count \\< 100,000 (1 point), and elevated CSF protein (1 point) was observed. \\[3\\] A total score of 9'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged from 2months up to 12 years admitted to the pediatric emergency department or pediatric ICU presented with Acute encephalopathy \\& meet diagnostic criteria of acute necrotizing encephalopathy or come for follow up in our outpatient clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Children aged from 2months up to 12 years admitted to the pediatric emergency department or pediatric ICU presented with Acute encephalopathy \\& meet diagnostic criteria of acute necrotizing encephalopathy or come for follow up in our outpatient clinic.\n\nExclusion Criteria:\n\n* Children known to have metabolic disease. Children who have picture of CNS infection \\& confirmed by CSF analysis.'}, 'identificationModule': {'nctId': 'NCT05853159', 'briefTitle': 'Clinical and Radiological Prognostic Factors of Acute Necrotizing Encephalopathy in Sohag University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Clinical and Radiological Prognostic Factors of Acute Necrotizing Encephalopathy in Sohag University Hospital', 'orgStudyIdInfo': {'id': 'Soh-med-23-04-07-MS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Basic Laboratory investigations , Cerebrospinal fluid analysis', 'type': 'OTHER', 'otherNames': ['MRI brain'], 'description': 'to detect severity and prognostic factors of Acute Necrotizing Encephalopathy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Marwa M fathy, resident', 'role': 'CONTACT', 'email': 'marwamahmoud@med.sohag.edu.eg', 'phone': '01033999370'}, {'name': 'Abdelrahim A Sadek, Professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatric and Neonatology Resident at Sohag University Hospital', 'investigatorFullName': 'Marwa Mahmoud Fathy', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-01-14', 'type': 'RELEASE'}, {'date': '2025-02-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Marwa Mahmoud Fathy, Pediatric and Neonatology Resident at Sohag University Hospital, Sohag University'}}}}