Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT00702767
Status:
COMPLETED
Last Update Posted:
2008-06-24
First Post:
2008-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in 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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-23', 'studyFirstSubmitDate': '2008-06-19', 'studyFirstSubmitQcDate': '2008-06-19', 'lastUpdatePostDateStruct': {'date': '2008-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['This study was completed in October 2006'], 'conditions': ['Low Birth Weight']}, 'referencesModule': {'references': [{'pmid': '18829797', 'type': 'DERIVED', 'citation': 'Drenckpohl D, McConnell C, Gaffney S, Niehaus M, Macwan KS. Randomized trial of very low birth weight infants receiving higher rates of infusion of intravenous fat emulsions during the first week of life. Pediatrics. 2008 Oct;122(4):743-51. doi: 10.1542/peds.2007-2282.'}]}, 'descriptionModule': {'briefSummary': 'This study was completed in October 2006. No further participates are being recruited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All infants who are Appropriate for Gestational Age at Birth and who have a birthweight between 750-1500 grams will be enrolled in this study.'}, 'identificationModule': {'nctId': 'NCT00702767', 'briefTitle': 'Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants', 'nctIdAliases': ['NCT00516997'], 'organization': {'class': 'OTHER', 'fullName': 'OSF Healthcare System'}, 'officialTitle': 'Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants During the First Week of Life', 'orgStudyIdInfo': {'id': '05-060'}}, 'armsInterventionsModule': {'interventions': [{'name': 'INTRALIPIDS', 'type': 'DRUG', 'description': 'INTRAVENOUS FAT EMULSIONS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OSF Healthcare System', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Kamlesh S. Macwan, Neonatalogist', 'oldOrganization': "Children's Hospital of Illinois at OSF-Saint Francis Medical Center"}}}}