Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-02-28 @ 2:49 AM
Study NCT ID:
NCT04249193
Status:
COMPLETED
Last Update Posted:
2020-03-13
First Post:
2020-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulse Oximetry Measurement and Transfusions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001238', 'term': 'Asphyxia Neonatorum'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001803', 'term': 'Blood Transfusion'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-12', 'studyFirstSubmitDate': '2020-01-24', 'studyFirstSubmitQcDate': '2020-01-29', 'lastUpdatePostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in number of Intermittent hypoxia', 'timeFrame': 'Change in number of intermittent hypoxia before (approximately 8 hours) and after transfusion (approximately 8 hours).', 'description': 'An intermittent hypoxemia event is defined as a fall in oxygen saturations to less than 80% for \\>/= 10 secs and \\<3 minutes with a minimal time interval of 4 seconds between events.'}], 'secondaryOutcomes': [{'measure': 'Hypoxia', 'timeFrame': '8 hours prior to transfusion and 8 hours after transfusion.', 'description': 'Percent time with oxygen saturations less than 85%, 80% and 75%.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transfusion', 'Intermittent hypoxia'], 'conditions': ['Hypoxia Neonatal', 'Premature', 'Blood Transfusion']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this observational study was to determine if pRBC transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (VLBW) during the first six weeks of life. The impact on non-pRBC transfusions on the frequency of intermittent hypoxia was also assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Weeks', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Premature neonates', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 23+0 to 28+6 weeks gestational age at birth\n\nExclusion Criteria:\n\n* Infants with life-limiting diagnoses\n* Cyanotic heart disease\n* In utero fetal transfusion\n* Twin to twin transfusion syndrome\n* Isoimmune hemolytic disease\n* Severe acute hemorrhage\n* Acute shock\n* Sepsis with coagulopathy\n* Need for perioperative transfusion\n* Parents opposed to transfusion of blood\n* Parents with hemoglobinopathy or congenital anemia'}, 'identificationModule': {'nctId': 'NCT04249193', 'acronym': 'POMAT', 'briefTitle': 'Pulse Oximetry Measurement and Transfusions', 'organization': {'class': 'OTHER', 'fullName': 'Christiana Care Health Services'}, 'officialTitle': 'Effect of Blood Transfusions on Intermittent Hypoxic Episodes in Very Low Birth Weight Infants', 'orgStudyIdInfo': {'id': 'DDD603862'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transfusion', 'interventionNames': ['Other: Transfusion']}], 'interventions': [{'name': 'Transfusion', 'type': 'OTHER', 'description': 'pRBC and non-pRBC transfusions', 'armGroupLabels': ['Transfusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Kelley Z Kovatis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christiana Care Health Services, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christiana Care Health Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'Temple University Hospital', 'class': 'UNKNOWN'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'Pennsylvania Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Neonatologist', 'investigatorFullName': 'Kelley Kovatis', 'investigatorAffiliation': 'Christiana Care Health Services'}}}}