Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-29 @ 5:20 PM
Study NCT ID:
NCT01786759
Status:
UNKNOWN
Last Update Posted:
2013-02-08
First Post:
2013-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568346', 'term': 'ClinOleic'}, {'id': 'C545823', 'term': 'soybean oil, phospholipid emulsion'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-06', 'studyFirstSubmitDate': '2013-02-06', 'studyFirstSubmitQcDate': '2013-02-06', 'lastUpdatePostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'liver function', 'timeFrame': 'Change from Baseline in fatty acid at 7 days and 14 days', 'description': 'Total Bile Acid(TBA),alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(AKP),γ-glutamyl transpeptidase(GGT),total bilirubin(Tbi),Direct bilirubin(Dbi)'}], 'secondaryOutcomes': [{'measure': 'bile acid', 'timeFrame': 'Change from Baseline in fatty acid at 7 days and 14 days', 'description': 'cholic acid,deoxycholic acid,Chenodeoxycholic Acid,ursodeoxycholic acid,lithocholic acid,et al.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lipids', 'preterm infants', 'parenteral nutrition', 'liver function'], 'conditions': ['Preterm Infants']}, 'descriptionModule': {'briefSummary': 'The etiology of parenteral nutrition-associated cholestasis(PNAC)although elusive is thought to be multifactorial, and proposed theories also include problems arising from lipid emulsions, leading us to explore alternative products available elsewhere.So we compare the different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic tolerance in preterm infant.', 'detailedDescription': 'Parenteral nutrition (PN) has been widely and successfully used in the pediatric population for more than 40 years, the most serious and significant life-threatening complication today continues to be parenteral nutrition-associated cholestasis(PNAC). Parenteral nutrition-associated cholestasis is indeed the most worrisome complication because it is difficult to treat and may progress to eventual cirrhosis and liver failure namely parenteral nutrition-associated liver disease (PNALD).\n\nTwo types of lipid emulsions are currently used for adult as well as pediatric patients: one lipid emulsions prepared from soybean oil that are composed of long-chain triacylglycerols (LCTs), and the other lipid emulsions composed of 50% medium-chain triacylglycerols (MCTs) and 50% LCT soybean oil. A new lipid emulsion prepared from a mixture of soybean oil and olive oil contains only LCTs and has a lower proportion (20%) of polyunsaturated fatty acids(PUFAs)and 60% monounsaturated fatty acids (MUFAs). So we compare the different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic tolerance in preterm infant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants of both genders\n* Hospitalized\n* The parent of the infant agreed to participate by signing an informed consent form\n* Infants admitted hospital within 72 hours after birth(gestational age\\<37 weeks)\n* Birth weight \\<= 2000g\n* No PN support contraindications\n* Parenteral nutrition for 14 days or more\n* The parent of the infant is to sign an informed consent form prior to enrollment\n\nExclusion Criteria:\n\n* Receiving PN before screening\n* Enteral nutrition(EN)caloric\\>10%\n* Obstruction jaundice\n* Suspected or identified biliary tract atresia\n* Neonatal hepatitis\n* Infants with liver markers \\>2 times normal levels\n* Infants with renal markers \\>2 times normal levels\n* Congenital metabolic situations\n* Identified as having major chromosomal disease\n* Cytomegaoviyns(CMV), virus hepatitis and syphilis infection\n* Congenital or acquired immune deficiency'}, 'identificationModule': {'nctId': 'NCT01786759', 'briefTitle': 'Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion', 'orgStudyIdInfo': {'id': 'HFBA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LCT lipid emulsion', 'description': 'the LCT lipid emulsion is Intralipid', 'interventionNames': ['Drug: ClinOleic', 'Drug: Intralipid']}, {'type': 'EXPERIMENTAL', 'label': 'Olive oil lipid emulsion', 'description': 'the olive oil lipid emulsion is ClinOleic', 'interventionNames': ['Drug: ClinOleic', 'Drug: Intralipid']}], 'interventions': [{'name': 'ClinOleic', 'type': 'DRUG', 'description': 'the lipid of all-in-one, 0.5-3.5g/kg.d', 'armGroupLabels': ['LCT lipid emulsion', 'Olive oil lipid emulsion']}, {'name': 'Intralipid', 'type': 'DRUG', 'description': 'the lipid of all-in-one, 0.5-3.5g/kg.d', 'armGroupLabels': ['LCT lipid emulsion', 'Olive oil lipid emulsion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yexuan Tao, PhD', 'role': 'CONTACT', 'email': 'taoyexuan@hotmail.cm', 'phone': '13818334664'}, {'name': 'Wei Cai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ying Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kejun Zhou, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Qingya Tang, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lina Lu, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Xinhua hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ying Wang, PhD', 'role': 'CONTACT', 'email': 'wangying_ssmu@126.com', 'phone': '8613611884226'}], 'overallOfficials': [{'name': 'Wei Cai, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Xin Hua Hospital'}, {'name': 'Ying Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice-president', 'investigatorFullName': 'Wei Cai', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}