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The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New hydrolyzed infant formula | Experimental | New, extensively hydrolyzed infant formula |
|
| Commercially available infant formula | Active Comparator | Commercially available, extensively hydrolyzed infant formula. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extensively hydrolyzed whey infant formula | Other | New hydrolyzed infant formula. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain | Mean weight gain (g/day) from enrollment to 4 months of age. | 4 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo Sorensen, MD | Louisiana State University Health Sciences Center in New Orleans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Springs Health Partners | Colorado Springs | Colorado | United States | |||
| Pedia Research |
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| Extensively hydrolyzed casein infant formula | Other | Commercially available infant formula. |
|
|
| Newburgh |
| Indiana |
| 42301 |
| United States |
| Pedia Research | Owensboro | Kentucky | 42301 | United States |
| ARK-LA-Tex Pediatric Research | Bossier City | Louisiana | United States |
| The Clinical Trials Center | New Orleans | Louisiana | 70118 | United States |
| Clinical Research of Nevada | Las Vegas | Nevada | United States |
| Institute of Clinical Research | Mayfield Heights | Ohio | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Cyn3rgy Research | Gresham | Oregon | United States |
| Square-1 Clinical Research | Erie | Pennsylvania | United States |
| Alpha Clinical Research | Clarksville | Tennessee | United States |
| Jackson Clinic | Jackson | Tennessee | 38305 | United States |
| Scott & White Wells Branch Clinic | Austin | Texas | 78728 | United States |
| Scott & White Killeen Clinic | Killeen | Texas | 76543 | United States |
| DCOL Center for Research | Longview | Texas | United States |
| Southwest Children's Research Associates | San Antonio | Texas | 78229 | United States |
| Scott & White Temple | Temple | Texas | 76508 | United States |
| Tanner Clinic | Layton | Utah | United States |
| Clinical Research Partners | Richmond | Virginia | United States |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 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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