Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-03 @ 4:29 AM
Study NCT ID:
NCT05455333
Status:
UNKNOWN
Last Update Posted:
2022-08-12
First Post:
2022-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Interest of a Genetic Diagnosis in Early Infant Epilepsy, Paraclinical and Therapeutic Management, and Psychological Impact of Families
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-11', 'studyFirstSubmitDate': '2022-07-07', 'studyFirstSubmitQcDate': '2022-07-07', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of event densities', 'timeFrame': '4 month', 'description': 'The frequency of events (crises, going to the emergency room, hospitalizations) before and after genetic diagnosis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Early Infant Epilepsy']}, 'descriptionModule': {'briefSummary': 'To determine the paraclinical and therapeutic interest of genetic diagnosis in early onset epilepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged ≤ 12 years, hospitalized or followed at the Hautepierre Hospital of the University Hospitals of Strasbourg for primary epilepsy having started in the first 5 months of life, from 2010 to 2021.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged ≤ 12 years,\n* hospitalized or followed at the Hautepierre Hospital of the University Hospitals of Strasbourg for primary epilepsy having started in the first 5 months of life, from 2010 to 2021.\n\nExclusion Criteria:\n\n\\- Children with secondary epilepsy (with infection trauma)'}, 'identificationModule': {'nctId': 'NCT05455333', 'briefTitle': 'Clinical Interest of a Genetic Diagnosis in Early Infant Epilepsy, Paraclinical and Therapeutic Management, and Psychological Impact of Families', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Clinical Interest of a Genetic Diagnosis in Early Infant Epilepsy, Paraclinical and Therapeutic Management, and Psychological Impact of Families', 'orgStudyIdInfo': {'id': '8609'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Sends and returns questionnaires to families.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'contacts': [{'name': 'Anaïs PHILIPPE', 'role': 'CONTACT', 'email': 'Anais.philippe@chru-strasbourg.fr', 'phone': '+33 3 69 55 19 55'}, {'name': 'Marie Thérèse ABI WARDE', 'role': 'CONTACT', 'email': 'Marie-therese.abiwarde@chru-strasbourg.fr', 'phone': '+33 3 88 12 84 61'}, {'name': 'Anaïs PHILIPPE', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marie Thérèse ABI WARDE', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de Génétique Médicale IGMA - Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Anaïs PHILIPPE', 'role': 'CONTACT', 'email': 'Anais.philippe@chru-strasbourg.fr', 'phone': '+33 3 69 55 19 55'}, {'name': 'Marie Thérèse ABI WARDE', 'role': 'CONTACT', 'email': 'Marie-therese.abiwarde@chru-strasbourg.fr', 'phone': '+33 3 88 12 84 61'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}