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This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Infant Formula | Experimental | extensively hydrolyzed casein protein |
|
| Control Infant Formula | Active Comparator | extensively hydrolyzed casein protein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Infant Formula | Other | Feed Ad Libitum |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Interval weight gain per day | Day of Age (DOA) 14 to 119 |
| Measure | Description | Time Frame |
|---|---|---|
| Length | Interval length gain per day | Study Day (SD) 1 to DOA 119 |
| Head Circumference | Interval HC gain per day | Study Day (SD) 1 to DOA 119 |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Feeding and Stool Patterns Questionnaire | Parent completed questionnaire; 16 questions with 5 categories scaled in the negative direction | Exit or DOA 119 |
| Infant Behavior Questionnaire | Parent completed questionnaire; 22 questions with 5 categories scaled in the negative direction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlett Ramirez | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedPharmics, LLC | Phoenix | Arizona | 85015 | United States | ||
| Watching Over Mothers & Babies |
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| Control Infant Formula |
| Other |
Feed Ad Libitum |
|
| Stool Characteristics | Parent Completed Diary | Study Day (SD) 1 to DOA 119 |
| Formula Intake | Parent Completed Diary | Study Day (SD) 1 to DOA 119 |
| Exit or DOA 119 |
| Formula Satisfaction Questionnaire | Parent completed questionnaire; 13 questions of up to 5 categories scaled in the negative direction | Exit or DOA 119 |
| Tucson |
| Arizona |
| 85712 |
| United States |
| Paramount Research Solutions | College Park | Georgia | 30349 | United States |
| Springs Medical Research | Owensboro | Kentucky | 42303 | United States |
| MedPharmics, LLC | Metairie | Louisiana | 70006 | United States |
| MedPharmics, LLC | Gulfport | Mississippi | 30503 | United States |
| Quality Clinical Research Inc | Omaha | Nebraska | 68114 | United States |
| MedPharmics, LLC | Albuquerque | New Mexico | 87102 | United States |
| PMG Research of Peidmont Healthcare | Statesville | North Carolina | 28625 | 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 |
| Children's Hospital | Sioux Falls | South Dakota | 57105 | United States |
| Midsouth Center for Clinical Research | Memphis | Tennessee | 38116 | United States |
| Ventavia Research Group, Llc | Fort Worth | Texas | 76104 | United States |
| Ventavia Research Group | Houston | Texas | 77008 | United States |
| Ventavia Research Group, LLC | Plano | Texas | 75093 | United States |