Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-04-17 @ 9:38 PM
Study NCT ID:
NCT02476994
Status:
TERMINATED
Last Update Posted:
2021-07-21
First Post:
2015-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'C536647', 'term': 'Pena Shokeir syndrome, type 1'}, {'id': 'D012778', 'term': 'Short Bowel Syndrome'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545823', 'term': 'soybean oil, phospholipid emulsion'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joe_archer@baxter.com', 'title': 'Clinical Trials Disclosure Group', 'organization': 'Baxter Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Clinolipid (Lipid Injectable Emulsion, USP) 20%', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nClinolipid", 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intralipid 20% (Lipid Injectable Emulsion, USP)', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nIntralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Essential Fatty Acid Deficiency (EFAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinolipid (Lipid Injectable Emulsion, USP) 20%', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nClinolipid"}, {'id': 'OG001', 'title': 'Intralipid 20% (Lipid Injectable Emulsion, USP)', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nIntralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"}], 'timeFrame': 'Up to 90 Days', 'description': 'Holman Index Calculation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, no formal analysis was conducted.'}, {'type': 'SECONDARY', 'title': 'Parenteral Nutrition-Associated Cholestasis (PNAC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinolipid (Lipid Injectable Emulsion, USP) 20%', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nClinolipid"}, {'id': 'OG001', 'title': 'Intralipid 20% (Lipid Injectable Emulsion, USP)', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nIntralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"}], 'timeFrame': 'Up to 90 Days', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, no formal analysis was conducted.'}, {'type': 'SECONDARY', 'title': 'Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinolipid (Lipid Injectable Emulsion, USP) 20%', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nClinolipid"}, {'id': 'OG001', 'title': 'Intralipid 20% (Lipid Injectable Emulsion, USP)', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nIntralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"}], 'timeFrame': 'Baseline', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, no formal analysis was conducted.'}, {'type': 'SECONDARY', 'title': 'Fatty Acid Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinolipid (Lipid Injectable Emulsion, USP) 20%', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nClinolipid"}, {'id': 'OG001', 'title': 'Intralipid 20% (Lipid Injectable Emulsion, USP)', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nIntralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"}], 'timeFrame': 'Up to 90 Days', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, no formal analysis was conducted.'}, {'type': 'SECONDARY', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinolipid (Lipid Injectable Emulsion, USP) 20%', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nClinolipid"}, {'id': 'OG001', 'title': 'Intralipid 20% (Lipid Injectable Emulsion, USP)', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nIntralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"}], 'timeFrame': 'Up to 90 Days', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, no formal analysis was conducted.'}, {'type': 'SECONDARY', 'title': 'Phytosterol, Cholesterol, and Squalene Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinolipid (Lipid Injectable Emulsion, USP) 20%', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nClinolipid"}, {'id': 'OG001', 'title': 'Intralipid 20% (Lipid Injectable Emulsion, USP)', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nIntralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"}], 'timeFrame': 'Up to 90 Days', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, no formal analysis was conducted.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinolipid (Lipid Injectable Emulsion, USP) 20%', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nClinolipid"}, {'id': 'OG001', 'title': 'Intralipid 20% (Lipid Injectable Emulsion, USP)', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nIntralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"}], 'timeFrame': 'Up to 90 Days', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, no formal analysis was conducted.'}, {'type': 'SECONDARY', 'title': 'Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinolipid (Lipid Injectable Emulsion, USP) 20%', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nClinolipid"}, {'id': 'OG001', 'title': 'Intralipid 20% (Lipid Injectable Emulsion, USP)', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nIntralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"}], 'timeFrame': 'Up to 90 Days', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, no formal analysis was conducted.'}, {'type': 'SECONDARY', 'title': 'Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinolipid (Lipid Injectable Emulsion, USP) 20%', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nClinolipid"}, {'id': 'OG001', 'title': 'Intralipid 20% (Lipid Injectable Emulsion, USP)', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nIntralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"}], 'timeFrame': 'Up to 90 Days', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, no formal analysis was conducted.'}, {'type': 'SECONDARY', 'title': 'Adverse Events and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinolipid (Lipid Injectable Emulsion, USP) 20%', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nClinolipid"}, {'id': 'OG001', 'title': 'Intralipid 20% (Lipid Injectable Emulsion, USP)', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nIntralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"}], 'timeFrame': "Up to 30 Days After Subject's Last Study Treatment", 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, no formal analysis was conducted.'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinolipid (Lipid Injectable Emulsion, USP) 20%', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nClinolipid"}, {'id': 'OG001', 'title': 'Intralipid 20% (Lipid Injectable Emulsion, USP)', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nIntralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"}], 'timeFrame': 'Up to 90 Days', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, no formal analysis was conducted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clinolipid (Lipid Injectable Emulsion, USP) 20%', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nClinolipid"}, {'id': 'FG001', 'title': 'Intralipid 20% (Lipid Injectable Emulsion, USP)', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nIntralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Based on feedback from FDA', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Clinolipid (Lipid Injectable Emulsion, USP) 20%', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nClinolipid"}, {'id': 'BG001', 'title': 'Intralipid 20% (Lipid Injectable Emulsion, USP)', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.\n\nIntralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Based on feedback from FDA', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'dispFirstSubmitDate': '2017-02-02', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2015-06-16', 'dispFirstSubmitQcDate': '2017-03-02', 'resultsFirstSubmitDate': '2017-10-31', 'studyFirstSubmitQcDate': '2015-06-17', 'dispFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-31', 'studyFirstPostDateStruct': {'date': '2015-06-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Essential Fatty Acid Deficiency (EFAD)', 'timeFrame': 'Up to 90 Days', 'description': 'Holman Index Calculation'}], 'secondaryOutcomes': [{'measure': 'Parenteral Nutrition-Associated Cholestasis (PNAC)', 'timeFrame': 'Up to 90 Days'}, {'measure': 'Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2', 'timeFrame': 'Baseline'}, {'measure': 'Fatty Acid Profile', 'timeFrame': 'Up to 90 Days'}, {'measure': 'Weight', 'timeFrame': 'Up to 90 Days'}, {'measure': 'Phytosterol, Cholesterol, and Squalene Levels', 'timeFrame': 'Up to 90 Days'}, {'measure': 'Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin)', 'timeFrame': 'Up to 90 Days'}, {'measure': 'Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake', 'timeFrame': 'Up to 90 Days'}, {'measure': 'Vital Signs', 'timeFrame': 'Up to 90 Days'}, {'measure': 'Adverse Events and Serious Adverse Events', 'timeFrame': "Up to 30 Days After Subject's Last Study Treatment"}, {'measure': 'Clinical Laboratory Tests', 'timeFrame': 'Up to 90 Days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Essential Fatty Acids (EFA)', 'Parenteral Nutrition', 'Clinolipid/Clinoleic', 'Parenteral Nutrition Associated Cholestasis (PNAC)', 'Parenteral Nutrition Associated Liver Disease (PNALD)', 'Intestinal Failure Associated Liver Disease (IFALD)', 'Phytosterols', 'Intralipid', 'Infants/Preterm Infants', 'FADS1 and FADS2', 'Short Bowel Syndrome', 'Cancer Nutrition', 'Olive Oil Emulsion', 'Soybean Oil Emulsion'], 'conditions': ['Essential Fatty Acid Deficiency (EFAD)']}, 'descriptionModule': {'briefSummary': 'This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid in a pediatric population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients and/or their legal representative must be able to understand the study and voluntarily sign the ICF\n2. Patients age \\<18 years\n3. Patients who are able to adhere to protocol requirements\n4. Patients who are expected to require PN for at least 7 days\n5. Premature infants (\\<36 weeks of gestation) require at least 80% PN to meet nutrition requirements at study entry; full term infants and children require at least 70% PN to meet nutrition requirements at study entry\n\nExclusion Criteria:\n\n1. Patients who are not expected to survive hospitalization or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation in the study\n2. Patients with a known hypersensitivity to lipid emulsion, egg or soybean proteins, or any of the active substances, excipients, or components of the container\n3. Patients with a diagnosis of shock, renal failure requiring dialysis, or severe metabolic acidosis (eg, pH \\<7.10, serum bicarbonate level ≤15 mEq/L , and/or an Anion Gap \\>16 mEq/L)\n4. Patients with hemodynamic instability as judged by the Investigator\n5. Patients with uncorrected metabolic disorders (eg, diabetes) or liver disease including cholestasis\n6. Patients with severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (triglyceride \\>400 mg/dL)\n7. Patients who are unable to tolerate the necessary laboratory monitoring\n8. Patients who have a new and active infection (as assessed by the investigator) at time of initiation of study treatment\n9. Patients who are enrolled in another clinical trial involving an investigational agent\n10. Patients who were treated with IV lipids within 48 hours of randomization into the study"}, 'identificationModule': {'nctId': 'NCT02476994', 'briefTitle': 'Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Baxter Healthcare Corporation'}, 'officialTitle': 'A Randomized, Double-Blind, Controlled, Clinical Trial to Evaluate the Risk of Developing Essential Fatty Acid Deficiency in Pediatric Patients, Including Neonates, Receiving Either Clinolipid (Lipid Injectable Emulsion, USP) 20% or Standard-of-Care Soybean Oil-Based Lipid Emulsion', 'orgStudyIdInfo': {'id': '6344-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinolipid (lipid injectable emulsion, USP) 20%', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.", 'interventionNames': ['Drug: Clinolipid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intralipid 20% (lipid injectable emulsion, USP)', 'description': "Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.", 'interventionNames': ['Drug: Intralipid']}], 'interventions': [{'name': 'Clinolipid', 'type': 'DRUG', 'armGroupLabels': ['Clinolipid (lipid injectable emulsion, USP) 20%']}, {'name': 'Intralipid', 'type': 'DRUG', 'description': 'Standard-of-Care Soybean Oil-Based Lipid Emulsion', 'armGroupLabels': ['Intralipid 20% (lipid injectable emulsion, USP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': "Advocate Children's Hospital", 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children at Indiana Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University, Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of SC, Neonatology', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Baxter Healthcare Corporation', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Baxter Healthcare Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}