Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-06 @ 5:04 AM
Study NCT ID:
NCT03706651
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2018-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Tele-expertise for the Interpretation of MRI Among Neonates With High Risk of Neurological Sequelae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002534', 'term': 'Hypoxia, Brain'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2018-09-24', 'studyFirstSubmitQcDate': '2018-10-10', 'lastUpdatePostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time between MRI and decision of intensive care continuation', 'timeFrame': '1 week after discharge', 'description': 'A cerebral MRI for neonates, prescribed by the ICU team, will be performed, requiring a specialist advice. This advice is mandatory for ICU team to decide the intensive care continuation.'}], 'secondaryOutcomes': [{'measure': 'Time between MRI and the specialist report', 'timeFrame': '1 week after discharge'}, {'measure': 'Time between MRI and the discussions with the parents', 'timeFrame': '1 week after discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypoxia, Brain']}, 'referencesModule': {'references': [{'pmid': '18328928', 'type': 'BACKGROUND', 'citation': 'Larroque B, Ancel PY, Marret S, Marchand L, Andre M, Arnaud C, Pierrat V, Roze JC, Messer J, Thiriez G, Burguet A, Picaud JC, Breart G, Kaminski M; EPIPAGE Study group. Neurodevelopmental disabilities and special care of 5-year-old children born before 33 weeks of gestation (the EPIPAGE study): a longitudinal cohort study. Lancet. 2008 Mar 8;371(9615):813-20. doi: 10.1016/S0140-6736(08)60380-3.'}, {'pmid': '22617736', 'type': 'BACKGROUND', 'citation': 'Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.'}], 'seeAlsoLinks': [{'url': 'http://www.renewinghealth.eu/assessment-method', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether tele-expertise would be more effective and more cost-effective for the Interpretation of MRI Among Neonates with high risk of neurological sequelae'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants hospitalized in neonatology unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Less than 28 days of life\n* Mandatory to have a medical advice in paediatric neuroradiology for interpretation of brain MRI\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03706651', 'acronym': 'Matrix Neonat', 'briefTitle': 'Assessment of Tele-expertise for the Interpretation of MRI Among Neonates With High Risk of Neurological Sequelae', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Assessment of Tele-expertise for the Interpretation of MRI Among Neonates With High Risk of Neurological Sequelae', 'orgStudyIdInfo': {'id': 'TLM-MatrixNeonat'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposed group, during Tele-expertise', 'description': 'Infants hospitalized in health facilities performing tele-expertise', 'interventionNames': ['Device: Infants hospitalized in health facilities performing Tele-expertise']}, {'label': 'Exposed group, Prior Tele-expertise', 'description': 'Infants hospitalized in health facilities performing Tele-expertise prior implementation of Tele-expertise'}], 'interventions': [{'name': 'Infants hospitalized in health facilities performing Tele-expertise', 'type': 'DEVICE', 'armGroupLabels': ['Exposed group, during Tele-expertise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Service de radiopédiatrie', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Service de Radiopédiatrie. Hôpital Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Service de radiopédiatrie. Hôpital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Service de radiopédiatrie - Hôpital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Elisabeth Dion, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de téléradiologie, Assistance Publique, Hôpitaux de Paris'}, {'name': 'Isabelle Durand-Zaleski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DRCD URC Eco. Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': "Agence Regionale de Sante d'Ile de France", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}