Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-27 @ 1:09 AM
Study NCT ID:
NCT00131859
Status:
COMPLETED
Last Update Posted:
2009-08-13
First Post:
2005-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diffusion-Tensor Magnetic Resonance Imaging (MRI) and the Evaluation of Perinatal Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056324', 'term': 'Diffusion Tensor Imaging'}], 'ancestors': [{'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D038524', 'term': 'Diffusion Magnetic Resonance Imaging'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-12', 'studyFirstSubmitDate': '2005-08-18', 'studyFirstSubmitQcDate': '2005-08-18', 'lastUpdatePostDateStruct': {'date': '2009-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diffusion-tensor imaging differences between brain injured cases and controls without brain injury', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Umbilical cord gas results', 'timeFrame': '2 years'}, {'measure': 'Placental pathology', 'timeFrame': '2 years'}, {'measure': 'Electronic fetal monitoring', 'timeFrame': '2 years'}, {'measure': 'Nucleated red blood cells', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Perinatal brain injury', 'Diffusion-tensor imaging'], 'conditions': ['Brain Injury, Fetus and Neonate']}, 'descriptionModule': {'briefSummary': "The researchers' objective is to use diffusion-tensor imaging (DTI) to evaluate infants diagnosed with cerebral white matter injury during the neonatal period and identify antenatal risk factors, electronic fetal heart rate monitoring abnormalities, and umbilical arterial gas results that are associated with cerebral white matter injury. The researchers' hypothesis is that this new imaging technique will help us better understand how these devastating injuries occur.", 'detailedDescription': 'Maternal and neonatal data will be collected as well as the umbilical arterial gas results and the electronic fetal heart rate tracing of the labor. Infants will have a head ultrasound at 24-72 hours, 10-14 days, and at 4-6 weeks to look for cerebral white matter injury, as standard of care. All infants with a birth weight \\< 1500 grams will be offered DTI, and infants \\> 1500 grams with white matter injury diagnosed by ultrasound will be imaged as well as the subsequent delivery born within 7 days of that gestational age without brain injury. All infants will have the DTI brain scan at 12-18 months of age corrected for the degree of prematurity, and will also have a formal neurological assessment at that time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '23 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Neonates \\< 1500 grams, with suspected brain injury, and with severe metabolic acidosis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All infants born at our hospital at \\< 1500 grams\n* All infants born at our hospital at \\> 1500 grams with brain injury or severe metabolic acidosis\n\nExclusion Criteria:\n\n* Major congenital malformations\n* Chromosomal abnormality'}, 'identificationModule': {'nctId': 'NCT00131859', 'briefTitle': 'Diffusion-Tensor Magnetic Resonance Imaging (MRI) and the Evaluation of Perinatal Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Diffusion-Tensor Magnetic Resonance Imaging and the Evaluation of Perinatal Brain Injury', 'orgStudyIdInfo': {'id': '04-08-31-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Diffusion-tensor imaging', 'type': 'PROCEDURE', 'otherNames': ['No other names applicable.'], 'description': 'Obtain a Diffusion tensor MRI of brain.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287-1228', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Ernest M Graham, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Univ; Dept. of Gyn-Ob'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hugo W. Moser Research Institute at Kennedy Krieger, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Ernie Graham, M.D.', 'oldOrganization': 'Johns Hopkins University School of Medicine'}}}}