Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-30 @ 9:36 AM
Study NCT ID:
NCT01585935
Status:
COMPLETED
Last Update Posted:
2018-01-09
First Post:
2012-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Cholestasis Using SMOFLipid®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000709826', 'term': 'SMOFlipid'}, {'id': 'D017404', 'term': 'In Situ Hybridization, Fluorescence'}, {'id': 'D000069463', 'term': 'Olive Oil'}, {'id': 'C545823', 'term': 'soybean oil, phospholipid emulsion'}, {'id': 'D013024', 'term': 'Soybean Oil'}], 'ancestors': [{'id': 'D017403', 'term': 'In Situ Hybridization'}, {'id': 'D013194', 'term': 'Staining and Labeling'}, {'id': 'D016591', 'term': 'Histocytological Preparation Techniques'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D020732', 'term': 'Cytogenetic Analysis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D009693', 'term': 'Nucleic Acid Hybridization'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2011-11-08', 'size': 2368315, 'label': 'Study Protocol and Statistical Analysis Plan: v 1.0', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-11-15T16:11', 'hasProtocol': True}, {'date': '2012-03-09', 'size': 2046359, 'label': 'Study Protocol and Statistical Analysis Plan: v 1.1', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-11-15T16:12', 'hasProtocol': True}, {'date': '2012-09-17', 'size': 2045080, 'label': 'Study Protocol and Statistical Analysis Plan: v 1.2', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-11-15T16:13', 'hasProtocol': True}, {'date': '2013-08-22', 'size': 2030820, 'label': 'Study Protocol and Statistical Analysis Plan: v 1.3', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_003.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-01-06T06:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-06', 'studyFirstSubmitDate': '2012-04-16', 'studyFirstSubmitQcDate': '2012-04-24', 'lastUpdatePostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Brain maturational scores assessed by amplitude integrated EEG (aEEG)', 'timeFrame': 'Participants will be followed for the duration of hospital stay (expected average 14 weeks)', 'description': 'aEEG measurements of study infants performed as a part of clinical routine (as specified in the trial study protocol v 1.0-1.3)'}, {'measure': 'Visual Evoked Potentials (VEP)', 'timeFrame': 'Participants will be followed for the duration of hospital stay (expected average 14 weeks)', 'description': 'VEP measurements of study infants performed as a part of clinical routine (as specified in the trial study protocol v 1.0-1.3)'}], 'primaryOutcomes': [{'measure': 'Incidence of parenteral nutrition associated cholestasis (PNAC)', 'timeFrame': 'Participants will be followed for the duration of hospital stay (expected average 14 weeks)', 'description': 'PNAC definition: Two consecutive conjugated bilirubin measurements \\> 1.5 mg/dl'}], 'secondaryOutcomes': [{'measure': 'Bailey Scales of Infant Development III', 'timeFrame': 'At 12 and 24 months corrected gestational age', 'description': 'Cognitive, Motor and Language Development'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infant, Extremely Low Birth Weight', 'Parenteral Nutrition', 'Fish Oils', 'Cholestasis', 'Psychomotor Disorders, Developmental'], 'conditions': ['Cholestasis', 'Psychomotor Disorders, Developmental']}, 'referencesModule': {'references': [{'pmid': '36257349', 'type': 'DERIVED', 'citation': 'Thanhaeuser M, Steyrl D, Fuiko R, Brandstaetter S, Binder C, Thajer A, Huber-Dangl M, Haiden N, Berger A, Repa A. A secondary Outcome Analysis of a Randomized Trial Using a Mixed Lipid Emulsion Containing Fish Oil in Infants with Extremely Low Birth Weight: Cognitive and Behavioral Outcome at Preschool Age. J Pediatr. 2023 Mar;254:68-74.e3. doi: 10.1016/j.jpeds.2022.10.014. Epub 2022 Oct 17.'}, {'pmid': '32590001', 'type': 'DERIVED', 'citation': 'Thanhaeuser M, Fuiko R, Oberleitner-Leeb C, Brandstaetter S, Binder C, Thajer A, Huber-Dangl M, Haiden N, Pablik E, Berger A, Repa A. A Randomized Trial of Parenteral Nutrition Using a Mixed Lipid Emulsion Containing Fish Oil in Infants of Extremely Low Birth Weight: Neurodevelopmental Outcome at 12 and 24 Months Corrected Age, A Secondary Outcome Analysis. J Pediatr. 2020 Nov;226:142-148.e5. doi: 10.1016/j.jpeds.2020.06.056. Epub 2020 Jun 23.'}, {'pmid': '31030946', 'type': 'DERIVED', 'citation': 'Binder C, Giordano V, Thanhaeuser M, Kreissl A, Huber-Dangl M, Longford N, Haiden N, Berger A, Repa A, Klebermass-Schrehof K. A Mixed Lipid Emulsion Containing Fish Oil and Its Effect on Electrophysiological Brain Maturation in Infants of Extremely Low Birth Weight: A Secondary Analysis of a Randomized Clinical Trial. J Pediatr. 2019 Aug;211:46-53.e2. doi: 10.1016/j.jpeds.2019.03.039. Epub 2019 Apr 25.'}, {'pmid': '29269199', 'type': 'DERIVED', 'citation': 'Repa A, Binder C, Thanhaeuser M, Kreissl A, Pablik E, Huber-Dangl M, Berger A, Haiden N. A Mixed Lipid Emulsion for Prevention of Parenteral Nutrition Associated Cholestasis in Extremely Low Birth Weight Infants: A Randomized Clinical Trial. J Pediatr. 2018 Mar;194:87-93.e1. doi: 10.1016/j.jpeds.2017.11.012. Epub 2017 Dec 18.'}], 'seeAlsoLinks': [{'url': 'http://www.fwf.ac.at/en/about-the-fwf/corporate-policy/', 'label': 'Homepage of the Austrian Science Fund (FWF)'}, {'url': 'http://www.meduniwien.ac.at/homepage/service/vienna-general-hospital-akh/en/', 'label': 'Vienna General Hospital, Medical University of Vienna'}]}, 'descriptionModule': {'briefSummary': 'Preterm infants of extreme low birth weight (ELBW, \\< 1000 gram birth weight) cannot immediately be nourished with mother´s or formula milk and are typically dependent on parenteral nutrition (PN) for a prolonged period of time. This puts them at risk for liver complications of PN, namely parenteral nutrition associated cholestasis (PNAC).\n\nIntravenous lipid emulsions (ILE) based on soy bean oil are standard of care for provision of energy and essential fatty acids in preterm infants. However, they might be implicated in the pathogenesis of PNAC.\n\nILEs based on pure fish oil are proposed for therapy of PNAC. Recently a lipid emulsion containing 15 % fish oil together with soy bean, olive and MCT oil has become available in Europe (SMOFLIPID®). Such a balanced lipid emulsion might be more favourable than the standard soy bean oil emulsion (Intralipid®) concerning the development of PNAC. Furthermore ILEs containing fish oil might exert a positive effect on neurodevelopment. However, there are no data so far.\n\nThe study aims to evaluate the fish oil containing ILE "SMOFlipid®" for its protective effect against PNAC in ELBW infants compared to standard treatment with the soy bean based ILE "Intralipid®". Furthermore neurodevelopment at 12 and 24 months of corrected gestational age will be investigated.', 'detailedDescription': 'BACKGROUND: Extreme low birth weight infants (ELBW, \\< 1000 gram birth weight) are typically dependent on parenteral nutrition (PN) for a prolonged period of time. This puts them at risk for development of liver complications of PN, namely parenteral nutrition associated cholestasis (PNAC).\n\nIntravenous lipid emulsion (ILE) based on soy bean oil are standard of care in preterm infants, but might be implicated in the pathogenesis of PNAC. Fish oil is rich in omega-3 long chain polyunsaturated fatty acids (LC-PUFA) that particularly accumulate in liver and brain of the fetus during the last trimester of pregnancy. In pediatric patients, ILEs based on pure fish oil are proposed as a rescue therapy of PNAC.\n\nRecently a mixed lipid emulsion containing 15 % fish oil together with soy bean , olive and MCT oil has become available for PN in Europe. Such a balanced lipid emulsion might be more favourable than the standard soy bean oil emulsion (Intralipid®) concerning the development of PNAC. Furthermore ILEs containing fish oil might exert a positive effect on neurodevelopment. However there are no data so far.\n\nAIM: To evaluate a fish oil containing ILE (SMOFlipid®) for its prophylactic effect on PNAC in ELBW infants compared to a soy bean based ILE (Intralipid®).\n\nSTUDY DESIGN: Double blind prospective randomized trial.\n\n* Primary Outcome: PNAC defined as two conjugated bilirubin \\> 1.5 mg/dl measurements on two consecutive occasions.\n* Secondary Outcome: The most important secondary outcome is neurodevelopment at 12 and 24 months of corrected age.\n* Exploratory Outcomes: Brain maturation measured by amplitude integrated EEG (aEEG) and flashed visual evoked potentials as available from clinical routine examinations\n\nHYPOTHESIS: The use of a mixed lipid emulsion containing fish oil (SMOFLIPID®) will reduce the incidence of PNAC compared to a standard soy bean oil based lipid emulsion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Birth weight ≤ 1000 Gram\n* Admission to the neonatal ward in the first 24 hours of life\n* Informed consent and randomization in the first 5 days of life\n\nExclusion Criteria:\n\n* Triplets or higher\n* Conjugated bilirubin \\> 1.5 mg/dl before inclusion to the study\n* Conditions associated with cholestasis independent of parenteral nutrition, i.e. inborn errors of metabolism, viral infections (cytomegaly virus, HIV, Hep B, Hep C), immune mediated hemolytic disease (Rhesus incompatibility), cystic fibrosis and any other primary cholestatic disease\n* Congenital neurological malformations for secondary outcome'}, 'identificationModule': {'nctId': 'NCT01585935', 'briefTitle': 'Preventing Cholestasis Using SMOFLipid®', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Preventing Cholestasis in Premature Infants Using SMOFLipid®', 'orgStudyIdInfo': {'id': 'MUV-Neo2'}, 'secondaryIdInfos': [{'id': '2011-005456-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smoflipid', 'description': 'SMOFLIPID will be used for parenteral lipid supply', 'interventionNames': ['Drug: SMOFLIPID']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intralipid', 'description': 'INTRALIPID will be used for parenteral lipid supply', 'interventionNames': ['Drug: INTRALIPID']}], 'interventions': [{'name': 'SMOFLIPID', 'type': 'DRUG', 'otherNames': ['SMOFLIPID (mixture of soy, fish, MCT and olive oil)'], 'description': 'target dose: 3g/kg/d', 'armGroupLabels': ['Smoflipid']}, {'name': 'INTRALIPID', 'type': 'DRUG', 'otherNames': ['INTRALIPID (soy bean oil)'], 'description': 'target dose: 3g/kg/d', 'armGroupLabels': ['Intralipid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Andreas Repa, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University Vienna'}, {'name': 'Nadja Haiden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Vienna'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After publication for 10 years.', 'ipdSharing': 'YES', 'description': 'After publication of the trial, we currently plan to share IPD upon personal request.', 'accessCriteria': 'We are planning to publish the protocols together with the statistical analysis plan as supplemental information. This however depends on the respective journal. Otherwise please request the study protocol together with the statistical analysis plan from the study director andreas.repa@meduniwien.ac.at'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof.MD.', 'investigatorFullName': 'Nadja Haiden,MD', 'investigatorAffiliation': 'Medical University of Vienna'}}}}