Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-27 @ 9:38 PM
Study NCT ID:
NCT05215366
Status:
UNKNOWN
Last Update Posted:
2022-01-31
First Post:
2022-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Value of Copeptin Assay in Children With Febrile Seizures at Sohag University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-11-07', 'releaseDate': '2023-01-22'}], 'estimatedResultsFirstSubmitDate': '2023-01-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003294', 'term': 'Seizures, Febrile'}], 'ancestors': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-18', 'studyFirstSubmitDate': '2022-01-18', 'studyFirstSubmitQcDate': '2022-01-18', 'lastUpdatePostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Value of copeptin assay in children with febrile seizures at Sohag University Hospital', 'timeFrame': '8 months', 'description': 'Serum copeptin venous blood samples (3 ml) will be obtained from children with FS (within 3 hours of seizures) as well as the two control groups. .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Febrile Seizure']}, 'referencesModule': {'references': [{'pmid': '26286537', 'type': 'BACKGROUND', 'citation': 'Patel N, Ram D, Swiderska N, Mewasingh LD, Newton RW, Offringa M. Febrile seizures. BMJ. 2015 Aug 18;351:h4240. doi: 10.1136/bmj.h4240. No abstract available.'}, {'pmid': '30038660', 'type': 'BACKGROUND', 'citation': 'Leung AK, Hon KL, Leung TN. Febrile seizures: an overview. Drugs Context. 2018 Jul 16;7:212536. doi: 10.7573/dic.212536. eCollection 2018.'}, {'pmid': '30605489', 'type': 'BACKGROUND', 'citation': 'Pechmann A, Wellmann S, Stoecklin B, Kruger M, Zieger B. Increased von Willebrand factor parameters in children with febrile seizures. PLoS One. 2019 Jan 3;14(1):e0210004. doi: 10.1371/journal.pone.0210004. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'Febrile seizures are one of the most common clinical diseases in pediatric neurology. It occurs between 6 months and 6 years of age and occurs in \\~2-5% of children. According to the age, frequency, duration, and type of seizures FS is divided into simple febrile seizures and complex febrile seizures Differentiation between febrile seizures and non-ictal events associated with fever such as shivering or dizziness is challenging. Therefore, precise diagnosis of FS after paroxysmal episodes associated with fever is often hindered by the lack of an objective biomarker With the widespread application of technologies, such as molecular biology, in medicine, some biomarkers for predicting or diagnosing FS have attracted attention. Imuekemhe et al in 1989 and 1996 found that lactic acid in the serum and cerebrospinal fluid of children with FS was significantly increased . Arginin-vasopressin hormone AVP released by the pituitary gland, has been shown to be involved in the thermoregulatory response to fever and convulsions Although AVP is unstable in the peripheral blood and, therefore, unsuited for diagnostic use the C-terminal portion of the AVP precursor copeptin has been recognized as a robust marker of AVP secretion . Wellman et al. found that the serum copeptin and Von Willebrand factor of children with FS were significantly higher than those of the control group .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '6 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include three groups of children (30 for each): children with febrile seizures (group 1), febrile children without seizures (group 2), and healthy control children (group 3).\n\nat Pediatric neurology outpatient clinic and Pediatric Department at Sohag University Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 6 months to 6 years.\n* Seizures.\n* Fever (≥38°C).\n\nExclusion Criteria:\n\n* Central nervous system infection.\n* Epilepsy.\n* Previous neurological abnormalities.\n* Inborn errors of metabolism.\n* Immunological diseases.\n* Endocrinal diseases (e.g., diabetes mellitus).\n* Obesity.\n* Eating disorders.\n* Gastrointestinal disorders (e.g., diarrhea).'}, 'identificationModule': {'nctId': 'NCT05215366', 'briefTitle': 'Value of Copeptin Assay in Children With Febrile Seizures at Sohag University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Value of Copeptin Assay in Children With Febrile Seizures at Sohag University Hospital', 'orgStudyIdInfo': {'id': 'Soh-Med-22-01-07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'children with febrile seizures', 'interventionNames': ['Diagnostic Test: copeptin biomarker in children with febrile seizures']}, {'label': 'febrile children without seizures', 'interventionNames': ['Diagnostic Test: copeptin biomarker in children with febrile seizures']}, {'label': 'healthy control children', 'interventionNames': ['Diagnostic Test: copeptin biomarker in children with febrile seizures']}], 'interventions': [{'name': 'copeptin biomarker in children with febrile seizures', 'type': 'DIAGNOSTIC_TEST', 'description': 'biomarkers increase in children with febrile seizures', 'armGroupLabels': ['children with febrile seizures', 'febrile children without seizures', 'healthy control children']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Osama R ElSherif, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Mahmoud A abd elrady, resident', 'role': 'CONTACT', 'email': 'mahmoud011175@med.sohag.edu.eg', 'phone': '01276923636'}, {'name': 'abd el rahim A Sadek, professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at pediateric department sohag university hospital', 'investigatorFullName': 'Mahmoud Ali Abdelrady', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-01-22', 'type': 'RELEASE'}, {'date': '2023-11-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mahmoud Ali Abdelrady, resident doctor at pediateric department sohag university hospital, Sohag University'}}}}