Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-25 @ 3:09 PM
Study NCT ID:
NCT03561168
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2018-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Review of Diagnostic Yield of MRI Brain Results in Children Under Age 3 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D007859', 'term': 'Learning Disabilities'}], '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'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 561}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2018-06-07', 'studyFirstSubmitQcDate': '2018-06-18', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Etiologic diagnosis obtained from MRI brain', 'timeFrame': '1 year', 'description': 'Determine the incidence of brain MRI abnormality that led to etiological explanation of developmental delay, autism or seizure.'}], 'secondaryOutcomes': [{'measure': 'Quantify anesthetic exposure', 'timeFrame': '1 year', 'description': 'To determine the doses of all anesthetic and sedative agents administered and the duration of anesthesia'}, {'measure': 'Incidence of repeat MRI', 'timeFrame': '1 year', 'description': 'To determine the incidence of repeat MRI scan in the study population. anesthesia. To determine the incidence of repeat MRI scan in the study population.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric', 'MRI Indications', 'Anesthesia', 'Anesthetic Neurotoxicity', 'MRI Diagnostic Yield'], 'conditions': ['Seizures', 'Development Delay', 'Anesthetic Neurotoxicity']}, 'referencesModule': {'references': [{'pmid': '28457518', 'type': 'BACKGROUND', 'citation': 'Murias K, Moir A, Myers KA, Liu I, Wei XC. Systematic review of MRI findings in children with developmental delay or cognitive impairment. Brain Dev. 2017 Sep;39(8):644-655. doi: 10.1016/j.braindev.2017.04.006. Epub 2017 Apr 27.'}, {'pmid': '12562474', 'type': 'BACKGROUND', 'citation': 'Simpson GA, Colpe L, Greenspan S. Measuring functional developmental delay in infants and young children: prevalence rates from the NHIS-D. Paediatr Perinat Epidemiol. 2003 Jan;17(1):68-80. doi: 10.1046/j.1365-3016.2003.00459.x.'}, {'pmid': '17607144', 'type': 'BACKGROUND', 'citation': 'Rodriguez DP, Poussaint TY. Neuroimaging of the child with developmental delay. Top Magn Reson Imaging. 2007 Feb;18(1):75-92. doi: 10.1097/RMR.0b013e3180f63511.'}, {'pmid': '15739114', 'type': 'BACKGROUND', 'citation': 'Decobert F, Grabar S, Merzoug V, Kalifa G, Ponsot G, Adamsbaum C, des Portes V. Unexplained mental retardation: is brain MRI useful? Pediatr Radiol. 2005 Jun;35(6):587-96. doi: 10.1007/s00247-005-1406-x. Epub 2005 Mar 1.'}, {'pmid': '9548639', 'type': 'BACKGROUND', 'citation': 'Schaefer GB, Bodensteiner JB. Radiological findings in developmental delay. Semin Pediatr Neurol. 1998 Mar;5(1):33-8. doi: 10.1016/s1071-9091(98)80016-8.'}, {'pmid': '27564559', 'type': 'BACKGROUND', 'citation': 'Huang YY, Li L, Monteleone M, Ferrari L, States LJ, Riviello JJ, Kernie SG, Mencin AA, Gupta S, Sun LS. Use of Anesthesia for Imaging Studies and Interventional Procedures in Children. J Neurosurg Anesthesiol. 2016 Oct;28(4):400-404. doi: 10.1097/ANA.0000000000000355.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to identify the frequency with which an elective brain MRI yields and etiologic diagnosis to explain its indication. The protocol includes children undergoing elective brain MRI with anesthesia prior to their third birthday.', 'detailedDescription': 'On December 14, 2016 the FDA issued a warning regarding elective anesthetics in children under three years of age. While a single, short exposure to general anesthesia may not have negative effects on behavior or learning, repeated or prolonged anesthetics may affect brain development. To that end, minimizing exposure to elective general anesthetics if procedures are not clearly indicated in young children appeals to reason.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1095 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children under age 3 undergoing MRI brain with anesthesia or sedation between Dec 13, 2015 and Dec 13, 2016', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 0-36 months who received anesthesia (volatile gas anesthesia) or IV sedation (propofol, dexmedetomidine, barbiturates, benzodiazepines, or other agents) for brain MRI\n\nExclusion Criteria:\n\n* MRI without sedation, brain MRI plus additional MRI imaging, i.e. spine, heart, etc., sedated MRI by a member of other department besides Anesthesiology.'}, 'identificationModule': {'nctId': 'NCT03561168', 'briefTitle': 'Review of Diagnostic Yield of MRI Brain Results in Children Under Age 3 Years', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Retrospective Review of Indications and Results of Brain MRI With Anesthesia/Sedation in Children Less Than Three Years of Age', 'orgStudyIdInfo': {'id': 'H-41288'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Developmental Delay', 'description': 'Children under age 3 who underwent MRI brain with anesthesia for the indication of Developmental Delay (between the dates of Dec 13, 2015 - Dec 13, 2016) at our institution.', 'interventionNames': ['Diagnostic Test: Change in plan of care based on MRI results']}, {'label': 'Seizure', 'description': 'Children under age 3 who underwent MRI brain with anesthesia for the indication of Seizure (between the dates of Dec 13, 2015 - Dec 13, 2016) at our institution.', 'interventionNames': ['Diagnostic Test: Change in plan of care based on MRI results']}, {'label': 'Developmental Delay and Seizure', 'description': 'Children under age 3 who underwent MRI brain with anesthesia for the indication of Developmental Delay and Seizure (between the dates of Dec 13, 2015 - Dec 13, 2016) at our institution.', 'interventionNames': ['Diagnostic Test: Change in plan of care based on MRI results']}], 'interventions': [{'name': 'Change in plan of care based on MRI results', 'type': 'DIAGNOSTIC_TEST', 'description': 'Study subjects have "received the intervention" if the results of their MRI either 1. provide an etiology for said MRI\'s indication or 2. the patient received a change in plan of care based on MRI results.', 'armGroupLabels': ['Developmental Delay', 'Developmental Delay and Seizure', 'Seizure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Dean B Andropoulos, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Baylor College of Medicine'}, {'name': 'Jamie W Sinton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This is a retrospective study, this question seems not applicable.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jamie Sinton', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}