Healthy Term Infants Clinical Trial
Official title:
The Evaluation of Cow's Milk Formula - Study B
Verified date | April 2009 |
Source | Mead Johnson Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
A study to evaluate the growth and development of term infants fed either a marketed cow's milk formula, or an experimental cow's milk formula with prebiotics + a different calcium source + a different level of fatty acids and fat, or an experimental cow's milk formula with prebiotic + a different calcium source + a different level of fatty acids and fat
Status | Completed |
Enrollment | 399 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 16 Days |
Eligibility |
Inclusion Criteria: - Term infant - 12-16 days of age - 37-42 weeks GA Exclusion Criteria: - History of chronic disease, congenital malformation - Feeding difficulties or formula intolerance - LGA |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
United States | Central Arkansas Pediatric Clinic | Benton | Arkansas |
United States | Birmingham Pediatric Group | Birmingham | Alabama |
United States | Retina Foundation of the Southwest | Dallas | Texas |
United States | Alabama Clinical Therapeutics | Dothan | Alabama |
United States | Medical Associates | Fayetteville | Arkansas |
United States | Holston Medical Group | Kingsport | Tennessee |
United States | Holston Medical Group, MeadowView Lane | Kingsport | Tennessee |
United States | Arkansas Children's Hospital Research Institute | Little Rock | Arkansas |
United States | Arkansas Pediatric Clinic | Little Rock | Arkansas |
United States | DCOL Center for Clinical Research | Longview | Texas |
United States | Texas Tech University Health Sciences Center | Lubbock | Texas |
United States | Odyssey Research | Minot | North Dakota |
United States | Welborn Clinic Research | Newburgh | Indiana |
United States | Southwestern Medical Clinic, PC | Niles | Michigan |
United States | Norwich Pediatric Group, PC | Norwich | Connecticut |
United States | The Center for Human Nutrition | Omaha | Nebraska |
United States | Red Lion Pediatrics | Philadelphia | Pennsylvania |
United States | Primary Physicians Research, Inc | Pittsburgh | Pennsylvania |
United States | Aspen Medical Group | St. Paul | Minnesota |
United States | Southwestern Medical Clinic, PC | Stevensville | Michigan |
United States | Palm Beach Clinical Investigation, LLC | West Palm Beach | Florida |
United States | Woburn Pediatric Associates Research Department | Woburn | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mead Johnson Nutrition |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of weight gain | 106 days | Yes | |
Secondary | length and head circumference | 106 days | Yes |
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