Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-01-01 @ 8:07 PM
Study NCT ID:
NCT01330095
Status:
COMPLETED
Last Update Posted:
2011-04-06
First Post:
2011-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Administration of Bifidobacterium to Very Low Birth Weight Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-05', 'studyFirstSubmitDate': '2011-04-01', 'studyFirstSubmitQcDate': '2011-04-05', 'lastUpdatePostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the day at total feeding volume reached 100ml/kg/day', 'timeFrame': 'post natal day', 'description': 'the post natal day at total enteral feeding reached 100ml/kg/day'}], 'secondaryOutcomes': [{'measure': 'colonizatin of Bifidobacterium', 'timeFrame': '4 weeks after birth', 'description': 'the level of Bifidobacterium in feces from the study infants growth rate of the study infants the positive rate of MRSA colonization among the study infants adverse outcomes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bifidobacterium bifidum', 'Very low birth weight infant', 'Enteral feeding', 'Growth', 'amount of enteral feeding'], 'conditions': ['Preterm Infants']}, 'referencesModule': {'references': [{'pmid': '22507386', 'type': 'DERIVED', 'citation': 'Yamasaki C, Totsu S, Uchiyama A, Nakanishi H, Masumoto K, Washio Y, Shuri K, Ishida S, Imai K, Kusuda S. Effect of Bifidobacterium administration on very-low-birthweight infants. Pediatr Int. 2012 Oct;54(5):651-6. doi: 10.1111/j.1442-200X.2012.03649.x. Epub 2012 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effects of early administration of probiotics on acceleration of enteral feeding, and on growth of very low birth weight infants, newborn infants with birth weight less than 1500g are administered Bifidobacterium bifidum twice a day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Very low birth weight infant\n\nExclusion Criteria:\n\n* Presence of major congenital malformations'}, 'identificationModule': {'nctId': 'NCT01330095', 'briefTitle': 'Early Administration of Bifidobacterium to Very Low Birth Weight Infants', 'organization': {'class': 'OTHER', 'fullName': "Tokyo Women's Medical University"}, 'officialTitle': 'Early Administration of Bifidobacterium Bifidum to Very Low Birth Weight Infants: A Pilot Study', 'orgStudyIdInfo': {'id': '1016'}, 'secondaryIdInfos': [{'id': 'UMIN000005245', 'type': 'OTHER', 'domain': 'University hospital Medical Information Network'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Eearly administration', 'description': 'Administration of Bifidobacterium within 48h after birth', 'interventionNames': ['Dietary Supplement: Administration of Bifidobacterium bifidum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Late administration', 'description': 'Administration of Bifidobacterium more than 48h after birth', 'interventionNames': ['Dietary Supplement: Administration of Bifidobacterium bifidum']}], 'interventions': [{'name': 'Administration of Bifidobacterium bifidum', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Bifidobacterium bifidum OLB6378'], 'description': 'Administration of Bifidobacterium bifidum to very low birth weight infants', 'armGroupLabels': ['Eearly administration', 'Late administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '162-8666', 'city': 'Shinjuku', 'state': 'Tokyo', 'country': 'Japan', 'facility': "Tokyo Women's Medical Unversity", 'geoPoint': {'lat': 35.69115, 'lon': 139.70854}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Tokyo Women's Medical University", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Satoshi Kusuda', 'oldOrganization': "Tokyo Women's Medical Center"}}}}