Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT00681018
Status:
COMPLETED
Last Update Posted:
2010-08-31
First Post:
2008-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feeding Study in Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-30', 'studyFirstSubmitDate': '2008-05-15', 'studyFirstSubmitQcDate': '2008-05-19', 'lastUpdatePostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight gain', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Feeding tolerance', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['premature', 'infants'], 'conditions': ['Premature Infants']}, 'descriptionModule': {'briefSummary': 'To evaluate weight gain of preterm infants fed fortified human milk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '40 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* premature infant\n* birth weight less than/equal to 1250 g\n* exclusively breast fed\n\nExclusion Criteria:\n\n* metabolic or chronic disease\n* major surgery\n* ventilator dependent'}, 'identificationModule': {'nctId': 'NCT00681018', 'briefTitle': 'Feeding Study in Premature Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'officialTitle': 'Feeding Study in Premature Infants', 'orgStudyIdInfo': {'id': '3379-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Liquid human milk fortifier', 'interventionNames': ['Other: Liquid human milk fortifier']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Powder human milk fortifier', 'interventionNames': ['Other: Powder human milk fortifier']}], 'interventions': [{'name': 'Liquid human milk fortifier', 'type': 'OTHER', 'otherNames': ['No other names -- experimental product'], 'description': 'Liquid human milk fortifier added to human milk', 'armGroupLabels': ['1']}, {'name': 'Powder human milk fortifier', 'type': 'OTHER', 'otherNames': ['Enfamil Human Milk Fortifier'], 'description': 'Powder human milk fortifier added to human milk', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'The University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33317', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Plantation General Hospital', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "All Children's Hospital", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': "Advocate Hope Children's Hospital", 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': "Advocate Lutheran General Children's Hospital", 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': "Children's Hospital", 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '11432', 'city': 'Jamaica', 'state': 'New York', 'country': 'United States', 'facility': "Queen's Hospital", 'geoPoint': {'lat': 40.69149, 'lon': -73.80569}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pitt County Memorial Hospital', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '28402', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'SEAHEC', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Forsyth Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '22046', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Fairfax Hospital', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Carol Lynn Berseth, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mead Johnson Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Carol Lynn Berseth, M.D.', 'oldOrganization': 'Mead Johnson'}}}}