Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-28 @ 11:40 AM
Study NCT ID:
NCT06211192
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2023-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What Are the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compile risk elements linked to extended use of anti-seizure medication retrospectively', 'timeFrame': '1-2 years', 'description': "Collecting the risk elements associated with long-term usage of anti-seizure medication from the participants' medical records in a retrospective manner."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neonate', 'Seizure', 'Early onset epilepsy', 'anti-seizure medication', 'acute provoke seizure'], 'conditions': ['Neonatal Seizure']}, 'descriptionModule': {'briefSummary': 'The investigators aimed to determine the factors for ceasing anti-seizure medication in infants who experienced seizures during the neonatal period. This retrospective, single-center, descriptive study was conducted in Balıkesir between December 2020 and February 2023, and 157 neonates were recruited.', 'detailedDescription': 'This retrospective, single-center, descriptive study was conducted at the Department of Paediatric Neurology between December 2020 and February 2023, and 157 neonates were recruited to determine the factors related to ceasing ASM treatment in infants at a follow-up 2 years. According to the International League Against Epilepsy (ILAE) classification of neonatal seizures and their etiology, patients who were diagnosed with such seizures and received anti-seizure medication within the first 28 days of life were followed until their ASM was ceased after they were discharged from the neonatal intensive care unit. Infants are defined as children aged younger than 12 months. During this stage of neuronal development, the central nervous system is more susceptible to the harmful effects of external factors. Consequently, the investigators have planned to evaluate the study\'s initial 12-month follow-up results for our group. Afterwards, the infants were divided into two groups: the first group consisted of infants who continued to receive ASM treatment after 12 months of age (referred to as "infants still on ASM after 12 months", n=69); the second group consisted of infants who had stopped ASM treatment before 12 months of age (referred to as "infants who had ceased ASM before 12 months", n=88).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '1 Hour', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Infants are defined as children aged younger than 12 months.According to the International League Against Epilepsy (ILAE) classification of neonatal seizures and their aetiology, patients who were diagnosed with such seizures and received anti-seizure medication within the first 28 days of life were followed until their ASM was ceased after they were discharged from the neonatal intensive care unit.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Neonates with seizures diagnosed clinically or with conventional electroencephalography (cEEG) confirmation were enrolled.\n\nExclusion Criteria:\n\n* with abnormal paroxysmal events that weren't determined to be seizures by cEEG, amplitude integrated EEG (aEEG) and video records,\n* stopped medications due to their parents' decisions,\n* with missing hospital records,\n* delivered from pregnancies by assisted reproductive techniques were not enrolled."}, 'identificationModule': {'nctId': 'NCT06211192', 'briefTitle': 'What Are the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures?', 'organization': {'class': 'OTHER', 'fullName': 'Balikesir University'}, 'officialTitle': 'Evaluation of the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures: A Single-center Retrospective Study', 'orgStudyIdInfo': {'id': 'YDKtreat'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'the first group consisted of infants who continued to receive ASM treatment after 12 months of age (referred to as "infants still on ASM after 12 months", n=69)', 'interventionNames': ['Other: retrospective data collection']}, {'label': 'Group 2', 'description': 'the second group consisted of infants who had stopped ASM treatment before 12 months of age (referred to as "infants who had ceased ASM before 12 months", n=88)', 'interventionNames': ['Other: retrospective data collection']}], 'interventions': [{'name': 'retrospective data collection', 'type': 'OTHER', 'description': 'retrospective data collecting from medical records', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10100', 'city': 'Balıkesir', 'state': 'Altieylul', 'country': 'Turkey (Türkiye)', 'facility': 'Orkun Çetin', 'geoPoint': {'lat': 39.64917, 'lon': 27.88611}}], 'overallOfficials': [{'name': 'Mustafa Kösecik, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Balikesir Üniversite Medical faculty hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balikesir University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'İpek Dokurel', 'investigatorAffiliation': 'Balikesir University'}}}}