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The control product was recalled.
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The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infant Formula #1 | Active Comparator | Milk-based Infant Formula Powder |
|
| Investigational Infant Formula #1 | Experimental | Investigational Milk-based Infant Formula Powder |
|
| Investigational Infant Formula #2 | Experimental | Investigational Milk based infant formula powder |
|
| Human Milk | Active Comparator | Reference group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk based infant formula powder | Other | milk based infant formula ad lib |
| |
| Measure | Description | Time Frame |
|---|---|---|
| weight gain | 14 to 119 days of age |
| Measure | Description | Time Frame |
|---|---|---|
| GI tolerance | 14 to 119 days of age | |
| anthropometrics | 14 to 119 days of age |
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Inclusion Criteria:
Exclusion Criteria:
adverse maternal, fetal or infant medical history with potential for effects on tolerance, growth, and/or development.
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| Name | Affiliation | Role |
|---|---|---|
| Timberly Williams, PhD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital Research | Little Rock | Arkansas | 72202 | United States | ||
| Facey Medical Foundation |
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| Investigational Infant Formula #1 |
| Other |
Milk based infant formula ad lib |
|
| Investigational Infant Formula #2 | Other | Milk based infant formula powder ad lib |
|
| Human Milk | Other | Human milk ad lib |
|
| Mission Hills |
| California |
| 91345 |
| United States |
| Norwich Pediatric Group | Norwich | Connecticut | 06360 | United States |
| All Women's Healthcare of West Broward, Inc | Plantation | Florida | 33324 | United States |
| SCORE Physician Alliance LLC | St. Petersburg | Florida | 33710 | United States |
| USF College of Medicine, USF Health, Department of Pediatrics | Tampa | Florida | 33606 | United States |
| Northpoint Pediatrics | Indianapolis | Indiana | 46038 | United States |
| University of Louisville Department of Pediatrics | Louisville | Kentucky | 40202 | United States |
| New England Center for Clinical Research, Inc | Fall River | Massachusetts | 02720 | United States |
| Wayzata Children's Clinic Ridgeview Research | Chaska | Minnesota | 55318 | United States |
| Midwest Children's Health Research Institute, LLC | Lincoln | Nebraska | 68504 | United States |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89123 | United States |
| Cary Pediatric Center | Cary | North Carolina | 27518 | United States |
| Dayton Clinical Research | Dayton | Ohio | 45406 | United States |
| Ohio Pediatric Research Association, Inc | Huber Heights | Ohio | 45424 | United States |
| Parma Pediatrics | Parma | Ohio | 44129 | United States |
| Comprehensive Pediatrics, Inc | Westlake | Ohio | 44145 | United States |
| Sanford Clinic Family Medicine 34th and Kiwanis | Sioux Falls | South Dakota | 57105 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | United States |
| Rockwood Clinic North Pediatrics | Spokane | Washington | 99218 | United States |
| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |
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