Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT01982357
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2013-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Neonatal Microvascular Hemodynamics Using Non-invasive Optical Technologies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007235', 'term': 'Infant, Premature, Diseases'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, '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': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-28', 'studyFirstSubmitDate': '2013-11-05', 'studyFirstSubmitQcDate': '2013-11-05', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Normal Blood flow in premature infant', 'timeFrame': 'up to 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infant, Premature, Diseases']}, 'descriptionModule': {'briefSummary': 'Alterations to microvascular blood flow in premature infants, are known to contribute to several major disease entities.\n\nThe optically-measured tissue blood flow, to determine tissue perfusion that can be use to detect blood loss.', 'detailedDescription': 'The researchers want to use optical technologies to non-invasively detect blood flow that can tell the onset of blood loss. The research can measure blood flow in stable premature infants in the Neonatal Intensive Care Unit over the duration of several weeks.\n\nThe technologies are Laser Speckle Imaging and Diffuse Optical Spectroscopy.\n\nLaser Speckle Imaging non-contact imaging technology, is sensitive to blood flow in superficial tissues. Diffuse Optical Spectroscopy, a probe-based contact technology like pulse oximetry, measures hemoglobin concentrations and states deeper below the skin surface.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'minimumAge': '1 Minute', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be selected from University of California Irvine Medical Center at Neonate Intensive Care Unit', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* premature infants born or transferred to neonatal intensive care unit with a gestational age of 28-35 weeks\n\nExclusion Criteria:\n\n* NONE premature infants born or transferred to neonatal intensive care unit'}, 'identificationModule': {'nctId': 'NCT01982357', 'briefTitle': 'Measurement of Neonatal Microvascular Hemodynamics Using Non-invasive Optical Technologies', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Measurement of Neonatal Microvascular Hemodynamics Using Non-invasive Optical Technologies', 'orgStudyIdInfo': {'id': '20139505'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'premature infant', 'description': 'Laser Speckle Imaging and Diffuse Optical Spectroscopy', 'interventionNames': ['Device: Laser Speckle Imaging and Diffuse Optical Spectroscopy']}], 'interventions': [{'name': 'Laser Speckle Imaging and Diffuse Optical Spectroscopy', 'type': 'DEVICE', 'description': 'Laser Speckle Imaging and Diffuse Optical Spectroscopy', 'armGroupLabels': ['premature infant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UCIMC', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'overallOfficials': [{'name': 'Omid Fathi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beckman Laser Institute, UCI'}, {'name': 'Bernard Choi, PhD', 'role': 'STUDY_DIRECTOR', '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': 'Omid Fathi, M.D., Pediatrics', 'investigatorFullName': 'Beckman Laser Institute and Medical Center', 'investigatorAffiliation': 'University of California, Irvine'}}}}