Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-17 @ 12:11 PM
Study NCT ID:
NCT00666120
Status:
COMPLETED
Last Update Posted:
2008-04-24
First Post:
2008-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
Sponsor:
Organization:
Raw JSON
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Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants. Nutr J. 2009 Jun 19;8:27. doi: 10.1186/1475-2891-8-27.'}]}, 'descriptionModule': {'briefSummary': 'To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator.\n\nHypothesize there will be no difference between formula groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Days', 'minimumAge': '4 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton birth\n* Term infant at birth\n* Birth weight of 2500 g (5 lbs 8 oz) or more\n* 4 - 18 days of age at Study Visit 1\n\nExclusion Criteria:\n\n* History of underlying metabolic or chronic disease or congenital malformation\n* Infant switched formulas more than one time between birth and Study Visit 1\n* Known feeding problems at Study Visit 1'}, 'identificationModule': {'nctId': 'NCT00666120', 'briefTitle': 'Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'officialTitle': 'Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula', 'orgStudyIdInfo': {'id': '3370-6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': "Cow's milk based infant formula", 'interventionNames': ['Other: Enfamil LIPIL with iron']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': "Partially hydrolyzed cow's milk based infant formula", 'interventionNames': ['Other: Good Start Supreme with DHA and ARA']}], 'interventions': [{'name': 'Enfamil LIPIL with iron', 'type': 'OTHER', 'description': "cow's milk based infant formula", 'armGroupLabels': ['1']}, {'name': 'Good Start Supreme with DHA and ARA', 'type': 'OTHER', 'description': "partially hydrolzed cow's milk protein", 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Harvey Pediatrics', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72756', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Mercy Rogers Pediatric Clinic', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '92704', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Lovelace Scientific Resources', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa Bay Medical Research', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'facility': "Children's Medical Association", 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '60115', 'city': 'DeKalb', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Health Care", 'geoPoint': {'lat': 41.92947, 'lon': -88.75036}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Welborn Clinic', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Fomon Infant Nutrition Unit', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Research Associates', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pediatrics Clinical Trials Unit', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '42301', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pedia Research', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '71111', 'city': 'Bossier City', 'state': 'Louisiana', 'country': 'United States', 'facility': "Arklatex Children's Center", 'geoPoint': {'lat': 32.51599, 'lon': -93.73212}}, {'zip': '63044', 'city': 'Bridgeton', 'state': 'Missouri', 'country': 'United States', 'facility': 'Craig Spiegel, MD', 'geoPoint': {'lat': 38.767, 'lon': -90.41151}}, {'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'The Center for Human Nutrition', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68124', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Boystown', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop Pediatric Associates', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '27511', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cary Pediatric Center', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '75503', 'city': 'Texarkana', 'state': 'Texas', 'country': 'United States', 'facility': 'Collom and Carney Clinic', 'geoPoint': {'lat': 33.42513, 'lon': -94.04769}}], 'overallOfficials': [{'name': 'Carol 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'}}}}