Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-26 @ 4:16 PM
Study NCT ID:
NCT05043194
Status:
UNKNOWN
Last Update Posted:
2021-09-20
First Post:
2021-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014580', 'term': 'Ursodeoxycholic Acid'}], 'ancestors': [{'id': 'D003840', 'term': 'Deoxycholic Acid'}, {'id': 'D002793', 'term': 'Cholic Acids'}, {'id': 'D001647', 'term': 'Bile Acids and Salts'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002757', 'term': 'Cholanes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2021-09-01', 'studyFirstSubmitQcDate': '2021-09-03', 'lastUpdatePostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'direct bilirubin value of participants', 'timeFrame': 'up to 10 weeks', 'description': 'Weekly direct bilirubin values in μmol/L for preterm infants during hospitalization will be collected to assess the severity of cholestasis'}], 'secondaryOutcomes': [{'measure': 'The γ-GT activity level of participants', 'timeFrame': 'up to 10 weeks', 'description': 'Weekly γ-GT values in U/L for preterm infants during hospitalization will be collected to assess the severity of cholestasis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholestasis of Parenteral Nutrition']}, 'descriptionModule': {'briefSummary': 'This study aims to confirm whether the preventive use of ursodeoxycholic acid on the 5th day after birth in preterm infants who started parenteral nutrition therapy can reduce the occurrence of enteral nutrition-related cholestasis in preterm infants. This study examined the safety and efficacy of ursodeoxycholic acid (UDCA) in preventing Cholestasis Associated with Total Parenteral Nutrition in preterm infants.', 'detailedDescription': 'Investigators compared oral administration of UDCA prophylaxis with no prophylaxis in a randomized, open-label, proof-of-concept trial in preterm neonates with PN therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '28 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. admission to the hospital within 24 hours after birth\n2. gestational ages:28-32 weeks\n3. requiring TPN during the first days of life\n\nExclusion Criteria:\n\n1. major congenital abnormalities, chromosomal abnormality congenital intrauterine infection, genetic metabolic diseases structural liver abnormality\n2. surgical treatment was taken during hospitalization\n3. with severe symptoms of digestive system disease before TPN\n4. incompletion or withdrawal of treatment during hospitalization'}, 'identificationModule': {'nctId': 'NCT05043194', 'acronym': 'UDACPPNAC', 'briefTitle': 'Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'The Preventive Study of Ursodeoxycholic Acid(UDCA) on Total Parenteral Nutrition Cholestasis(PNAC) in Premature Infants', 'orgStudyIdInfo': {'id': 'wei liu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ursodeoxycholic acid arm', 'description': 'Premature infants who meet the inclusion criteria take preventive oral ursodeoxycholic acid on the 7th day after birth. ursodeoxycholic acid capsules (Ursofalk, 250 mg/capsules), starting with oral administration of pharmacologic doses of 20-25mg/kg/d, twice daily, until they were discharged .', 'interventionNames': ['Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule']}, {'type': 'SHAM_COMPARATOR', 'label': 'the control arm', 'description': 'The control group was treated with UDCA after the occurrence of cholestasis.ursodeoxycholic acid capsules (Ursofalk, 250 mg/capsules), starting with oral administration of pharmacologic doses of 20-25mg/kg/d, twice daily, until they were discharged .', 'interventionNames': ['Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule']}], 'interventions': [{'name': 'Ursodeoxycholic Acid 250 Mg Oral Capsule', 'type': 'DRUG', 'description': 'prevention', 'armGroupLabels': ['the control arm', 'ursodeoxycholic acid arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'wei liu, doctor', 'role': 'CONTACT', 'email': 'liuweistudy@126.com', 'phone': '027-83663332'}, {'name': 'siying liu, master', 'role': 'CONTACT', 'email': 'liusiying5200527@qq.com', 'phone': '027-83663332'}], 'facility': 'Wei Liu', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'liwen chang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wei Liu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Wei Liu', 'investigatorAffiliation': 'Tongji Hospital'}}}}