Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-29 @ 11:38 AM
Study NCT ID:
NCT01555957
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2012-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005217', 'term': 'Fat Emulsions, Intravenous'}], 'ancestors': [{'id': 'D004655', 'term': 'Emulsions'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D057947', 'term': 'Parenteral Nutrition Solutions'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sanjiv_amin@urmc.rochester.edu', 'phone': '585-273-2696', 'title': 'Sanjiv Amin', 'organization': 'University of Rochester'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '42 days', 'eventGroups': [{'id': 'EG000', 'title': 'Low Dose Intravenous Lipids', 'description': 'intravenous lipid: intravenous given daily for 6 weeks', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Dose of Intravenous Lipids', 'description': 'intravenous lipid: intravenous given daily for 6 weeks', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Parenteral Nutrition Associated Cholestasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Intravenous Lipids', 'description': 'intravenous lipid: intravenous given daily for 6 weeks'}, {'id': 'OG001', 'title': 'High Dose of Intravenous Lipids', 'description': 'intravenous lipid: intravenous given daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'we hypothesized that among ≥ 34 weeks GA infants with GISDs, infants receiving 1g/kg/day S-ILE (lipid minimizing strategy) would have decreased incidence of IFALD compared to those receiving 2g/kg/day S-ILE. We also hypothesized that the rate of rise of DB would be lower among ≥ 34 weeks GA infants with GISDs receiving 1g/kg/day versus 2g/kg/day of S-ILE.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 weeks', 'description': 'Defined as direct bilirubin ≥ 2mg/dl developing within one week of the completion of 6 week randomization period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Mean Rate of Change in Direct Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Intravenous Lipids', 'description': 'intravenous lipid: intravenous given daily for 6 weeks'}, {'id': 'OG001', 'title': 'High Dose of Intravenous Lipids', 'description': 'intravenous lipid: intravenous given daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.28'}, {'value': '0.19', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '0.32'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'We also hypothesized that the rate of rise of direct bilirubin would be lower among ≥ 34 weeks GA infants with GISDs receiving 1g/kg/day versus 2g/kg/day of S-ILE.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, weeks 1, 2, 3, 4, 5 and 6', 'description': 'Amount of direct (conjugated) bilirubin was measured from sera samples.', 'unitOfMeasure': 'mg/dL/week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose Intravenous Lipids', 'description': 'intravenous lipid: intravenous given daily for 6 weeks'}, {'id': 'FG001', 'title': 'High Dose of Intravenous Lipids', 'description': 'intravenous lipid: intravenous given daily for 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose Intravenous Lipids', 'description': 'intravenous lipid: intravenous given daily for 6 weeks'}, {'id': 'BG001', 'title': 'High Dose of Intravenous Lipids', 'description': 'intravenous lipid: intravenous given daily for 6 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '36.7', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '37.0', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-10', 'size': 256486, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-04T16:51', 'hasProtocol': True}, {'date': '2018-01-19', 'size': 229139, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-11-05T11:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The care taker team provided daily weight to the research pharmacist for calculating the dose of the lipid according to the assignment and then calculated the rate of administration over 18 to 24 hours depending on the volume. The rate and dose was masked to the investigators and participants.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-02', 'studyFirstSubmitDate': '2012-03-14', 'resultsFirstSubmitDate': '2020-11-05', 'studyFirstSubmitQcDate': '2012-03-14', 'lastUpdatePostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-02', 'studyFirstPostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Parenteral Nutrition Associated Cholestasis', 'timeFrame': '7 weeks', 'description': 'Defined as direct bilirubin ≥ 2mg/dl developing within one week of the completion of 6 week randomization period'}], 'secondaryOutcomes': [{'measure': 'Mean Rate of Change in Direct Bilirubin', 'timeFrame': 'baseline, weeks 1, 2, 3, 4, 5 and 6', 'description': 'Amount of direct (conjugated) bilirubin was measured from sera samples.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parenteral Nutrition Associated Cholestasis']}, 'descriptionModule': {'briefSummary': 'The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '72 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis, omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible for this study\n\nExclusion Criteria:\n\n1. If does not need TPN by 72 hours;\n2. Direct hyperbilirubinemia within the first 72 hours after birth;\n3. TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);\n4. Biliary tract disorders leading to direct hyperbilirubinemia;\n5. Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc"}, 'identificationModule': {'nctId': 'NCT01555957', 'briefTitle': 'Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Effect of Lipid Intake on Direct Hyperbilirubinemia in Late Preterm and Term Infants With Gastrointestinal Surgical Problems.', 'orgStudyIdInfo': {'id': 'URochester'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low dose intravenous lipids', 'interventionNames': ['Drug: intravenous lipid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'high dose of intravenous lipids', 'interventionNames': ['Drug: intravenous lipid']}], 'interventions': [{'name': 'intravenous lipid', 'type': 'DRUG', 'description': 'intravenous given daily for 6 weeks', 'armGroupLabels': ['high dose of intravenous lipids', 'low dose intravenous lipids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Sanjiv Amin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}, {'name': 'Kunal Gupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}