Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-03 @ 9:15 PM
Study NCT ID:
NCT01483703
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2011-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Noninvasive Optical Measurement of Critical Care Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012816', 'term': 'Signs and Symptoms'}], 'ancestors': [{'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081982', 'term': 'Laser Speckle Contrast Imaging'}], 'ancestors': [{'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-28', 'studyFirstSubmitDate': '2011-11-29', 'studyFirstSubmitQcDate': '2011-11-29', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medical tool', 'timeFrame': 'up to 12 months', 'description': "Laser Speckle Imaging device to image superficial cerebral blood flow in the infant's head"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Signs and Symptoms']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether reflections of light can be used to provide real-time pictures of blood vessel formation around infants' heads. This study device is called laser speckle imaging.", 'detailedDescription': "The researchers can use the laser speckle imaging device to image superficial cerebral blood flow in the infant's head. The researchers can quantify blood flow and measured vessel diameter, versus actual diameter assessed with conventional digital camera imaging."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Weeks', 'minimumAge': '1 Minute', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New born or infant\n\nExclusion Criteria:\n\n* non- new born or infant'}, 'identificationModule': {'nctId': 'NCT01483703', 'briefTitle': 'Noninvasive Optical Measurement of Critical Care Neonates', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Noninvasive Optical Measurement of Critical Care Neonates', 'orgStudyIdInfo': {'id': '20118163'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnostic tool', 'description': 'Laser Speckle Imaging of Critical Care Neonates', 'interventionNames': ['Device: Laser Speckle Imaging']}], 'interventions': [{'name': 'Laser Speckle Imaging', 'type': 'DEVICE', 'description': 'Laser Speckle Imaging of Critical Care Neonates', 'armGroupLabels': ['Diagnostic tool']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'CHOC', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'overallOfficials': [{'name': 'Bernard Choi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beckman Laser Institute, UCI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beckman Laser Institute University of California Irvine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Bernard Choi, Ph.D., Assistant Professor Biomedical Engineering', 'investigatorFullName': 'Beckman Laser Institute and Medical Center', 'investigatorAffiliation': 'University of California, Irvine'}}}}