Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-26 @ 7:36 AM
Study NCT ID:
NCT07241858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinicolaboratory Predictors of Outcome in Children With Encephalitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004660', 'term': 'Encephalitis'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To asses clinical ,radiological laboratory biomarkers ( CSF Neuron-Specific Enolase and S100B )as outcome predictors of encephalitis', 'timeFrame': '1 month', 'description': 'To asses clinical ,radiological laboratory biomarkers ( CSF Neuron-Specific Enolase and S100B )as outcome predictors of encephalitis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Encephalitis in Children', 'Encephalitis']}, 'referencesModule': {'references': [{'pmid': '40310303', 'type': 'BACKGROUND', 'citation': 'Makovec M, Skitek M, Simnovec L, Jerin A. Neuron-Specific Enolase and S100B as Biomarkers of Ischemic Brain Injury During Surgery. Clin Pract. 2025 Apr 3;15(4):74. doi: 10.3390/clinpract15040074.'}, {'pmid': '30232787', 'type': 'BACKGROUND', 'citation': 'Aneja S, Sharma S. Diagnosis and Management of Acute Encephalitis in Children. Indian J Pediatr. 2019 Jan;86(1):70-75. doi: 10.1007/s12098-018-2775-0. Epub 2018 Sep 19.'}, {'pmid': '21883688', 'type': 'BACKGROUND', 'citation': 'Shiihara T, Miyake T, Izumi S, Watanabe M, Kamayachi K, Kodama K, Nabetani M, Ikemiyagi M, Yamaguchi Y, Sawaura N. Serum and cerebrospinal fluid S100B, neuron-specific enolase, and total tau protein in acute encephalopathy with biphasic seizures and late reduced diffusion: a diagnostic validity. Pediatr Int. 2012 Feb;54(1):52-5. doi: 10.1111/j.1442-200X.2011.03454.x. Epub 2011 Oct 30.'}]}, 'descriptionModule': {'briefSummary': '. A glycolytic enzyme called enolase is primarily found in neurons. A dimeric isoform of enolase called neuron-specific enolase (NSE) exists. It can be found in neurons, platelets, erythrocytes, and other neuroectodermal cells.It is one of the laboratory biomarkers that could be investigated in cases of encephalopathy, which can be found in both blood and cerebrospinal fluid, might be a helpful biomarker for determining brain injury prognosis and neuronal damage.(4) High S-100beta levels were associated with higher intensive care unit mortality and represented the strongest independent predictor of intensive care unit survival, whereas neuron-specific enolase (NSE) and the Glasgow Coma Scale failed to predict fatal outcome.(5) (NSE) and S100B are important as a diagnostic and a prognostic value in pediatric encephalopathy which is common and is potentially life threatening, previous studies were done worldwide to detect its diagnostic and prognostic value in acute encephalopathy among adult and pediatric age groups.(4) ,so we asses (NSE) and S100B to detect the the out come of acute encephalopathy', 'detailedDescription': 'Acute encephalopathy is the generic term for acute brain dysfunction caused by various agents, such as infection, metabolic disease, hepatic or renal dysfunctions, and hypertension;causing change in mental status that affects cognition or level of alertness in the patient. The pathological substrate of acute encephalopathy is diffuse or widespread non-inflammatory brain edema..(1) The key for establishing evidence of central nervous system (CNS) inflammation is the analysis of CSF. Lumbar puncture (LP) is often excessively delayed, primarily due to performing brain imaging to exclude raised intracranial pressure. Not all patients need imaging before LP, and consensus guidelines suggest a few clear indications for imaging. If these are present, then either a computed tomography (CT) scan or, ideally, magnetic resonance imaging (MRI) should be obtained urgently. Following this, if there are no radiological contraindications, LP should be performed as soon as possible. Brain imaging serves three purposes: to look for changes of encephalitis, to exclude alternative diagnoses, and to assess patency of the basal cisterns and an absence of mass effect so that LP can proceed.(2) Biochemical markers can be used in addition to neuroimaging techniques to evaluate the extent of brain injuries and to enable earlier diagnosis and faster intervention. Among the potential biomarkers of brain injuries, neuron-specific enolase (NSE) and S100B are the most frequently studied and were shown to be the most promising.(3).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1\\. Pediatric population aged 1month to 18 years.\n\n* Decreased level of consciousness, personality change, or psychiatric manifestations lasting \\>24 h (in toddlers and infants, may present as increased irritability or lethargy)\n* No alternative diagnosis to explain presentation\n* Seizure (new onset)\n* Fever (≥38.0°C)\n* Focal neurologic findings (new onset)\n* CSF WBC ≥5/mm3\n* Acute abnormality on brain MRI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Pediatric population aged 1month to 18 years.\n\n * Decreased level of consciousness, personality change, or psychiatric manifestations lasting \\>24 h (in toddlers and infants, may present as increased irritability or lethargy)\n * No alternative diagnosis to explain presentation\n * Seizure (new onset)\n * Fever (≥38.0°C)\n * Focal neurologic findings (new onset)\n * CSF WBC ≥5/mm3\n\nExclusion Criteria:\n\n* 1\\. Neonates and adults ( \\<1 month or \\>18 years) 2. If they had a diagnosis of delirium or encephalopathy secondary to sepsis, toxins,renal ,hepatic or metabolic causes (hypoglycemia, electrolyte disturbances'}, 'identificationModule': {'nctId': 'NCT07241858', 'acronym': 'encephalitis', 'briefTitle': 'Clinicolaboratory Predictors of Outcome in Children With Encephalitis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Clinicolaboratory Predictors of Outcome in Children With Encephalitis', 'orgStudyIdInfo': {'id': 'pediatric encephalitis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with encephalitis', 'interventionNames': ['Diagnostic Test: CSF analysis and culture including S100B,Neuron Specific Enolase(NSE)']}], 'interventions': [{'name': 'CSF analysis and culture including S100B,Neuron Specific Enolase(NSE)', 'type': 'DIAGNOSTIC_TEST', 'description': 'CSF analysis and culture including S100B,Neuron Specific Enolase(NSE)', 'armGroupLabels': ['Children with encephalitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71717', 'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Noha Mostafa Sayed Mostafa', 'investigatorAffiliation': 'Assiut University'}}}}