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To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Infant Formula | Experimental | Infant formula powder to be fed ad libitum |
|
| Control Infant Formula | Active Comparator | Infant formula powder to be fed ad libitum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Infant Formula | Other | amino acid-based infant formula powder |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain | Infant scale | Study Day 14 to Study Day 119 |
| Measure | Description | Time Frame |
|---|---|---|
| GI tolerance | Parent completed questionnaires | Study Day 1 to Study Day 119 |
| Length | Length board | Study Day 1 to Study Day 119 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Kajzer, MS, RD, LD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | United States | ||
| Southeastern Pediatric Associates |
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| Control Infant Formula |
| Other |
amino acid-based infant formula powder |
|
| Head Circumference | Measure tape | Study Day 1 to Study Day 119 |
| Weight | Infant scale | Study Day 1 to Study Day 119 |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Watching Over Mothers and Babies | Tucson | Arizona | 85712 | United States |
| The Children's Clinic of Jonesboro, P.A. | Jonesboro | Arkansas | 72401 | United States |
| Norwich Pediatric Group, PC | Norwich | Connecticut | 06360 | United States |
| Children's Research, LLC | Lake Mary | Florida | 32746 | United States |
| Score Physician Alliance, LLC | St. Petersburg | Florida | 33710 | United States |
| Saltzer Medical Group | Nampa | Idaho | 83686 | United States |
| Deaconess Clinic, Inc. | Evansville | Indiana | 47713 | United States |
| Springs Medical Research | Owensboro | Kentucky | 42303 | United States |
| Women's Clinic of Lincoln, PC | Lincoln | Nebraska | 68510 | United States |
| Pediatric Associates of Fairfield, Inc. | Fairfield | Ohio | 45014 | United States |
| Institute of Clinical Research, LLC | Mentor | Ohio | 44060 | United States |
| The Cleveland Pediatric Research Center, LLC | Middleburg Heights | Ohio | 44130 | United States |
| Medical Research South | Charleston | South Carolina | 29407 | United States |
| Coastal Pediatric Research 3002 | Charleston | South Carolina | 29414 | United States |
| Coastal Pediatric Associates 3004 | Mt. Pleasant | South Carolina | 29464 | United States |
| Coastal Pediatric Research 3003 | North Charleston | South Carolina | 29406 | United States |
| Memphis & Shelby County Pediatric Group | Memphis | Tennessee | 38116 | United States |
| Vilo Research Group Inc | Houston | Texas | 77017 | United States |
| Southwest Children's Research Associates, PA | San Antonio | Texas | 78229 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |