Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-02-26 @ 8:31 AM
Study NCT ID:
NCT02676960
Status:
COMPLETED
Last Update Posted:
2025-10-17
First Post:
2016-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study: MRI on 6 Months, 1 Year, and 2 Years Old Children Without Sedation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2016-01-18', 'studyFirstSubmitQcDate': '2016-02-04', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants that can perform an MRI exam without sedation', 'timeFrame': 'From the time of the start of the MRI until the end of the MRI exam (~2 hours)', 'description': 'Perform MRI exam without sedation at a later age than newborn'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to perform brain scans using magnetic resonance imaging (MRI) instrument on children aged 6 months up to 5 year old children. This procedure is usually done with sedation but the study will see if it can be done without sedation.', 'detailedDescription': 'MRI examination of term infants without sedation at a later age (than newborn) can be feasible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Up to 15 healthy term infants age \\~6 months, up to 15 healthy term infants age \\~1 year and another up to 15 healthy toddlers at age 2 years, up to 15 healthy children age 3 to 5 years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term born\n* Mother is 18 years or older\n\nExclusion Criteria:\n\n* Any previous or current neurological illness or other serious medical conditions\n* Any conditions deemed by the investigators that are not suited for a MRI scan.'}, 'identificationModule': {'nctId': 'NCT02676960', 'briefTitle': 'Feasibility Study: MRI on 6 Months, 1 Year, and 2 Years Old Children Without Sedation', 'organization': {'class': 'OTHER', 'fullName': "Arkansas Children's Hospital Research Institute"}, 'officialTitle': 'Feasibility Study: MRI on 6 Months, 1 Year, and 2 Years Old Children Without Sedation', 'orgStudyIdInfo': {'id': '204890'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRI without sedation', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Nutrition Center", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Xiawei Ou, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Arkansas Children's Nutrition Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}