Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-01-31 @ 11:03 AM
Study NCT ID:
NCT03277768
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2017-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D004374', 'term': 'Ductus Arteriosus, Patent'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-06', 'studyFirstSubmitDate': '2017-09-01', 'studyFirstSubmitQcDate': '2017-09-06', 'lastUpdatePostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences and pre- and post-ductal RRS measurements of tissue oxygenation.', 'timeFrame': 'Up to a maximum of 14 data collection times', 'description': 'Pre- and post-ductal tissues oxygenation as measured by RRS may be more significant in infants with PDA.'}], 'secondaryOutcomes': [{'measure': 'Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events.', 'timeFrame': 'Up to a maximum of 14 data collection times', 'description': 'RRS measurements and the difference between pre- and post-ductal tissue oxygenation will be evaluated in infants with serious adverse events to determine if the measurements could have predicted the serious adverse event.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Premature infant', 'Tissue Oxygenation', 'Patent Ductus Arteriosus'], 'conditions': ['Premature Infant', 'Patent Ductus Arteriosus', 'Hemodynamic Instability']}, 'descriptionModule': {'briefSummary': 'The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This is a prospective observational study of infants born at \\< 30 weeks of gestation. The primary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in premature infants with PDA in comparison to infants without PDA. The secondary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Premature infants born \\<30 weeks gestational age and admitted to the Boston Children's Hospital neonatal intensive care unit (NICU), Brigham and Women's NICU, and the University of Florida NICU.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants \\< 30 weeks estimated gestational age\n\nExclusion Criteria:\n\n* Infants with major congenital anomalies\n* Infants \\>34 weeks post-menstrual age'}, 'identificationModule': {'nctId': 'NCT03277768', 'briefTitle': 'Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.', 'orgStudyIdInfo': {'id': 'IRB201601508'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group -Patent Ductus Arteriosus Absent', 'interventionNames': ['Device: Resonance Raman Spectroscopy (RRS)']}, {'label': 'Study Group - Patent Ductus Arteriosus Present', 'interventionNames': ['Device: Resonance Raman Spectroscopy (RRS)']}], 'interventions': [{'name': 'Resonance Raman Spectroscopy (RRS)', 'type': 'DEVICE', 'description': 'Pre and post-ductal RRS measurements will be obtained daily for a maximum of 14 data collection times in infants with and without PDAs.', 'armGroupLabels': ['Control Group -Patent Ductus Arteriosus Absent', 'Study Group - Patent Ductus Arteriosus Present']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'J Lauren Ruoss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The analysis of the data will be shared with other research. Individual patient data will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': "Boston Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}