Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT02006992
Status:
COMPLETED
Last Update Posted:
2013-12-12
First Post:
2013-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Growth of Infants Fed Hydrolysate Formulas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2000-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-11', 'studyFirstSubmitDate': '2013-12-05', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Study day 1 to 112 days of age'}], 'secondaryOutcomes': [{'measure': 'Length', 'timeFrame': 'Study day 1 to 112 days of age'}, {'measure': 'Head Circumference', 'timeFrame': 'Study day 1 to 112 days of age'}, {'measure': 'Study Formula Intake', 'timeFrame': 'Enrollment to 112 days of age'}, {'measure': 'Incidence of Spit Up', 'timeFrame': 'Enrollment to 112 days of age'}, {'measure': 'Stool Pattern', 'timeFrame': 'Enrollment to 112 days of age'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth and Tolerance']}, 'descriptionModule': {'briefSummary': 'Effects on weight and weight gain will be monitored in healthy term infants fed assigned infant formulas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants in good health.\n* Singleton, term birth with a gestational age of 37 to 42 weeks.\n* Birth weight of 2500 g (5 lb 8 oz) or greater.\n* Between 0 and 9 days of age at enrollment.\n* Not receiving vitamin or mineral supplements.\n\nExclusion Criteria:\n\n\\- Maternal, fetal or perinatal medical history with potential for adverse effects on growth or development.'}, 'identificationModule': {'nctId': 'NCT02006992', 'briefTitle': 'Growth of Infants Fed Hydrolysate Formulas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Growth of Infants Fed Hydrolysate Formulas', 'orgStudyIdInfo': {'id': 'AJ57'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RTF Infant Formula 1', 'description': 'a ready to feed (RTF) extensively hydrolyzed infant formula fed ad lib.', 'interventionNames': ['Other: RTF Infant Formula']}, {'type': 'EXPERIMENTAL', 'label': 'Powder Infant Formula 2', 'description': 'a powdered extensively hydrolyzed infant formula fed ad lib.', 'interventionNames': ['Other: Powder Infant Formula']}], 'interventions': [{'name': 'RTF Infant Formula', 'type': 'OTHER', 'description': 'a RTF extensively hydrolyzed infant formula', 'armGroupLabels': ['RTF Infant Formula 1']}, {'name': 'Powder Infant Formula', 'type': 'OTHER', 'description': 'a powdered extensively hydrolyzed infant formula.', 'armGroupLabels': ['Powder Infant Formula 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Aurora', 'state': 'Illinois', 'country': 'United States', 'facility': 'Dreyer Medical Center', 'geoPoint': {'lat': 41.76058, 'lon': -88.32007}}, {'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'PediaResearch, LLC', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'The University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Pediatric Research', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': "NC Children's & Young Adults' Clinical Research Foundation", 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Sellersville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GrandView Medical Research', 'geoPoint': {'lat': 40.35399, 'lon': -75.3049}}], 'overallOfficials': [{'name': 'Marlene Borschel, RD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}