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This is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental infant formula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infant formula, alternate protein source | Experimental | Experimental infant formula with alternate protein source |
|
| Infant formula powder | Active Comparator | Infant formula powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| experimental infant formula with alternate protein source | Other | experimental infant formula to be fed ad libitum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain | 119 days |
| Measure | Description | Time Frame |
|---|---|---|
| gastrointestinal tolerance | Stool characteristics, number of stools per day, and number of feedings associated with spit up or vomit | 119 days |
| Anthropometric variables | Length gain per day and head circumference gain per day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlene Borschel, PhD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwich Pediatric Group, PC | Norwich | Connecticut | 06360 | United States | ||
| SCORE Physician Alliance, LLC |
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| Infant formula powder | Other | powdered infant formula to be fed ad libitum |
|
| 119 days |
| St. Petersburg |
| Florida |
| 33710 |
| United States |
| Northpoint Pedicatrics, LLC | Indianapolis | Indiana | 46038 | United States |
| Springs Medical Research, LLC | Owensboro | Kentucky | 42303 | United States |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | United States |
| Cary Pediatric Center | Cary | North Carolina | 27518 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Ohio Pediatric Research Association, INC. | Huber Heights | Ohio | 45424 | United States |
| Institute of Clinical Research | Mayfield Heights | Ohio | 44124 | United States |
| The Cleveland Pediatric Research Center | Parma | Ohio | 44129 | United States |
| Sanford Clinic Family Medicine | Sioux Falls | South Dakota | 57105 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | United States |