Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 5:26 PM
Study NCT ID:
NCT00726206
Status:
COMPLETED
Last Update Posted:
2014-08-28
First Post:
2008-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-27', 'studyFirstSubmitDate': '2008-07-30', 'studyFirstSubmitQcDate': '2008-07-30', 'lastUpdatePostDateStruct': {'date': '2014-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To prove the predictive value of the " Deltas Brushes " triggered by hand or foot stimulation in correlation with the general movement analysis in the cerebral palsy diagnosis.', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': "To prove that the general movement of the preterm increases the predictive value the actual monitoring of the preterm's in the diagnosis of cerebral palsy.", 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The general movement and the electroencephalogram analysis of the preterm have a high predictive value of the neuro-developmental outcome of the infants.', 'detailedDescription': 'Compare the technical and the predictive characteristics of the qualitative analysis of the spontaneous motility with those of actual exams of reference diagnosis : magnetic resonance imaging, electroencephalogram and transfontanellar imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children been born between 15/01/08 and 15/01/10\n* children whose term is lower than 28 weeks of amenorrhoea\n\nExclusion Criteria:\n\n* Born child superior to 28 weeks of amenorrhoea\n* presenting child a genic syndrome, an evolutionary neurological disease, a pathology malformative'}, 'identificationModule': {'nctId': 'NCT00726206', 'briefTitle': "Correlation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy", 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': "Correlation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy", 'orgStudyIdInfo': {'id': '2008-A00062 53'}, 'secondaryIdInfos': [{'id': '2008-02'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Recording of the movements Recording of the electroencephalogram', 'interventionNames': ['Other: Electroencephalogram, recording the movements']}], 'interventions': [{'name': 'Electroencephalogram, recording the movements', 'type': 'OTHER', 'description': 'Electroencephalogram, recording the movements of the child, RMI, Transfontanel Imaging', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13915', 'city': 'Marseille', 'country': 'France', 'facility': 'Service de Médecine Infantile et Néonatologie, CHU Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Catherine GIRE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique des Hopitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}