Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-04-25 @ 1:29 PM
Study NCT ID:
NCT02372058
Status:
COMPLETED
Last Update Posted:
2015-09-11
First Post:
2015-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transcutaneous Bilirubinometry in Neonates With Bilicare System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'schutzmand@einstein.edu', 'phone': '215-456-6698', 'title': 'Dr. David L. Schutzman', 'organization': 'Albert Einstein Medical Center located in Philadelphia, Pennsylvania, USA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Late Preterm and Term Newborns', 'description': 'The study population will consist of term and late preterm newborns (infants \\>=35 weeks gestational age)', 'otherNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'BiliCare TcB Result Compared to TSB Result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BiliCare TcB Average', 'description': 'The study population will consist of term and late preterm newborns (infants \\>=35 weeks gestational age) measured with one BiliCare TcB device without an infection control tip and with one BiliCare TcB device with an infection control tip.\n\nThis is the average of both devices'}, {'id': 'OG001', 'title': 'JM103 TcB', 'description': 'The study population will consist of term and late preterm newborns (infants \\>=35 weeks gestational age) measured with the JM103 TcB device'}, {'id': 'OG002', 'title': 'Total Serum Bilirubin (TSB)', 'description': 'The study population will consist of term and late preterm newborns (infants \\>=35 weeks gestational age) measured routinely for total serum bilirubin by diazo method.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.46', 'spread': '2.68', 'groupId': 'OG000'}, {'value': '7.93', 'spread': '3.48', 'groupId': 'OG001'}, {'value': '7.83', 'spread': '3.27', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes within taking the blood draw for TSB (either before or after the blood draw)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Late Preterm and Term Newborns', 'description': 'The study population will consist of term and late preterm newborns (infants \\>=35 weeks gestational age)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Late Preterm and Term Newborns', 'description': 'The study population will consist of term and late preterm newborns (infants \\>=35 weeks gestational age)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'spread': '19.75', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Hours since birth', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Number of participants who completed the study'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-13', 'studyFirstSubmitDate': '2015-02-22', 'resultsFirstSubmitDate': '2015-08-13', 'studyFirstSubmitQcDate': '2015-02-22', 'lastUpdatePostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-13', 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BiliCare TcB Result Compared to TSB Result', 'timeFrame': '30 minutes within taking the blood draw for TSB (either before or after the blood draw)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['We Will Focus on Assessing the Clinical Performance of the BiliCare Device']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to define the performance evaluation of BiliCare TcB device to the "gold standard" bilirubin tests.', 'detailedDescription': 'Neonatal hyperbilirubinemia or newborn jaundice impacts over 85% of all newborns \\[1\\]. Regardless of the mechanism, excessive hyperbilirubinemia has been traditionally treated with phototherapy to minimize any probable risk of developing bilirubin-induced neurotoxicity. However, earlier and more recent data suggest that pre-discharge bilirubin screening for risk of significant hyperbilirubinemia, whether due to a rapid bilirubin production or an earlier age of onset, has impacted the guidelines for clinical use of phototherapy \\[1, 2\\]. In this study, we plan to test the performance of a novel transcutaneous device (BiliCareTM) first for screening for bilirubin levels at postnatal age of 6 to 48 hrs; and possibly also, to substitute the use of this measurement for total plasma/serum bilirubin (TB). This device applies a novel light transmission technology that has the potential to measure bilirubin as a point-of-care test in the subcutaneous tissue, and then uses an internal algorithm to calculate bilirubin levels in the skin. In this proposalstudy, we will to assess the clinical performance of the BiliCare by correlating measurements made by this device to near-concurrent measure of total plasma/serum bilirubin at normative ranges (mean, median, range and inter-quartile ranges ) for all term and late-preterm newborns (including those who are at-risk for jaundice and / or being administered with phototherapy) born to families of diverse race and ethnic backgrounds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parental informed consent\n* Male and female newborns with a GA ≥ 35 wks\n* Enrollment at age \\> 6 hrs until neonatal discharge.\n* Pre-phototherapy\n\nExclusion Criteria:\n\n* Infants requiring respiratory assistance (such as mechanical ventilation)\n* Severe or life-threatening congenital anomalies\n* Hematomas at the point of measurement on both ears\n* Neonates undergone blood transfusion'}, 'identificationModule': {'nctId': 'NCT02372058', 'briefTitle': 'Transcutaneous Bilirubinometry in Neonates With Bilicare System', 'organization': {'class': 'OTHER', 'fullName': 'Gerium Medical'}, 'officialTitle': 'Transcutaneous Bilirubinometry in Neonates With Bilicare System', 'orgStudyIdInfo': {'id': '10002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'BiliCare', 'description': 'Three non invasive measurements of TcB:\n\nTwo measurements with the BiliCare device and one measurement with a competitive FDA approved device', 'interventionNames': ['Device: BiliCare']}], 'interventions': [{'name': 'BiliCare', 'type': 'DEVICE', 'description': 'Three non invasive measurements of TcB:\n\nTwo measurements with the BiliCare device and one measurement with a competitive FDA approved device', 'armGroupLabels': ['BiliCare']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Einstein Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'David Schutzman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Einstein Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gerium Medical', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}