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| Name | Class |
|---|---|
| Validcare | UNKNOWN |
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A 4 month growth monitoring study of healthy term infants fed iron fortified infant formula. Infants will be fed ad-libitum for 16 weeks and growth will be evaluated in terms of weight gain over the 16 weeks.
A Growth Monitoring Study conducted according to FDA established guidelines to evaluate the test infant formulas ability to promote normal growth and development.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Formula 1_365 Day Grass-Fed Cow's Milk Infant Formula | Experimental | Infant formula meets all nutrient requirements of the FDA. |
|
| Study Formula 2_Goat Milk Infant Formula | Experimental | Infant Formula meets all nutrient requirements of the FDA. |
|
| Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein | Experimental | Infant Formula meets all nutrient requirements of the FDA. |
|
| Study Formula 4_USDA Organic iron fortified infant formula | Active Comparator | Infant Formula meets all nutrient requirements of the FDA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant Formula | Other | Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain (g) from study entry to 16 weeks of study. | Growth Monitoring Study | 16 weeks of Clinical Study |
| Measure | Description | Time Frame |
|---|---|---|
| Recumbent length gain (cm) from study entry to 16 weeks of study. | Growth Monitoring Study | 16 weeks of Clinical Study |
| Head Circumference gain (cm) from study entry to 16 weeks of study | Growth Monitoring Study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Aqua, MD | Backtee Holdings, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research-Phoenix | Phoenix | Arizona | 85006 | United States | ||
| Advance Pediatric Associates |
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Randomization and exclusive feeding of study formulas by 14 days of age. Breastfed Cohort will be evaluated over the 16 weeks.
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Study infant formulas have been blinded
| 16 weeks of Clinical Study |
| Tolerance of study formulas over 16 weeks of study | Tolerance of the infant to the study formulas will be evaluated 5 times through the use of study diaries for 3 days before each study visit. | 16 weeks of Clinical Study |
| Centennial |
| Colorado |
| 80015 |
| United States |
| Symphony Clinical Research | Jacksonville | Florida | 32216 | United States |
| Clintheory Healthcare Miami | North Miami Beach | Florida | 33162 | United States |
| PAS Research Tampa | Tampa | Florida | 33607 | United States |
| UpTo Trials | Tampa | Florida | 33612 | United States |
| Backtee Holdings, LLC | Wellington | Florida | 33414 | United States |
| Velocity Clinical Research-Macon | Macon | Georgia | 31210 | United States |
| Leavitt Clinical Research | Idaho Falls | Idaho | 83404 | United States |
| Kentucky Pediatric Research | Bardstown | Kentucky | 40004 | United States |
| Springs Medical Research | Owensboro | Kentucky | 42303 | United States |
| Magnolia Clinical Research, LLC | Lutcher | Louisiana | 70071 | United States |
| Velocity Clinical Research-Slidell, LA | Slidell | Louisiana | 70458 | United States |
| Frontier Pediatric Research, LLC | Lincoln | Nebraska | 68516 | United States |
| PAS Research Henderson | Henderson | Nevada | 89014 | United States |
| PAS Research Vegas | Las Vegas | Nevada | 89128 | United States |
| Velocity Clinical Research-Durham | Durham | North Carolina | 27701 | United States |
| Hightower Clinical-Oklahoma City | Oklahoma City | Oklahoma | 73114 | United States |
| Hightower Clinical-Shawnee | Shawnee | Oklahoma | 74804 | United States |
| Cyn3rgy | Gresham | Oregon | 97030 | United States |
| PAS Pittsburgh | Pittsburgh | Pennsylvania | 15227 | United States |
| Coastal Ped Research-Charleston | Charleston | South Carolina | 29414 | United States |
| Coastal Ped Research-Summerville | Summerville | South Carolina | 29486 | United States |
| AVIATI Healthcare & Clinical Research | Memphis | Tennessee | 38115 | United States |
| Helios Clinical Research-Burleson | Burleson | Texas | 76028 | United States |
| Helios Clinical Research-Houston | Houston | Texas | 77008 | United States |
| Prime Clinical Research, Inc | Mansfield | Texas | 76063 | United States |
| PAS Research McAllen | McAllen | Texas | 78504 | United States |
| Helios Clinical Research-Weatherford | Weatherford | Texas | 76086 | United States |
| ID | Term |
|---|---|
| D041943 | Infant Formula |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D005526 | Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |
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