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Raw ingredient shortage. Future study start date - TBD
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This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Marketed cow's milk-based infant formula |
|
| Investigational | Experimental | Cow's milk-based infant formula with added nutrients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marketed cow's milk-based infant formula | Other |
| ||
| Cow's milk-based infant formula with added nutrients |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of body weight gain from 14 to 120 days of age | 3.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recall of infant formula at each study visit | Up to 3.5 months | |
| Body length measured at each study visit | Up to 3.5 months | |
| Recall of stool characteristics questionnaire measured at each study visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Wu | Mead Johnson Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Pediatric Associates | Birmingham | Alabama | 35205 | United States | ||
| Southeastern Pediatric Associates |
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| Other |
|
| Up to 3.5 months |
| Head circumference measured at each study visit | Up to 3.5 months |
| Recall of gastrointestinal tolerance questionnaire at each study visit | Up to 3.5 months |
| Medically confirmed adverse events collected throughout the study period | Up to 3.5 months |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Northwest Arkansas Pediatric Clinic | Fayetteville | Arkansas | 72703 | United States |
| The Children's Clinic of Jonesboro, P.A. | Jonesboro | Arkansas | 72401 | United States |
| Norwich Pediatric Group, P.C. | Norwich | Connecticut | 06360 | United States |
| Altamonte Pediatric Associates | Lake Mary | Florida | 32746 | United States |
| Deaconess Clinical Research | Evansville | Indiana | 47725 | United States |
| Kentucky Pediatrics/Adult Research | Bardstown | Kentucky | 40004 | United States |
| Owensboro Pediatrics | Owensboro | Kentucky | 42303 | United States |
| Pediatric Associates of Mt. Carmel, Inc. | Cincinnati | Ohio | 45245 | United States |
| Ohio Pediatric Research Association | Dayton | Ohio | 45414 | United States |
| Pediatric Associates of Fairfield, Inc. | Fairfield | Ohio | 45014 | United States |
| UHMP Comprehensive Pediatrics | Westlake | Ohio | 44145 | United States |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | United States |
| The Jackson Clinic - North Jackson | Jackson | Tennessee | 38305 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | United States |