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This clinical trial will evaluate the growth, tolerance, and iron status of infants who consume an investigational infant formula containing a nutrient-rich whey protein compared to a previously marketed infant formula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previously marketed infant formula | Active Comparator | Cow's milk-based infant formula |
|
| Previously marketed formula using a similar protein | Experimental | Cow's milk-based infant formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Previously marketed infant formula | Other |
| ||
| Previously marketed formula using a similar protein |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight measured at each study visit | Measurement collected with a calibrated infant scale | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body length measured at each study visit | Measurement collected with a standardized length board | 12 months |
| Head circumference measured at each study visit | Measurement collected with a standardized measuring tape |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Wu, M.D. | Mead Johnson and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Pediatric Associates | Birmingham | Alabama | 35205 | United States | ||
| Southeastern Pediatric Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37929831 | Derived | Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2. |
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| Other |
|
| 12 months |
| Parental recall of study formula intake at each study visit | 12 months |
| Parental recall of stool consistency measured at each study visit | 12 months |
| Blood Collection | Composite measure of hemoglobin, hematocrit, ferritin, and c-reactive protein | Once at 12 months |
| Medically-confirmed adverse events collected throughout the study period | 12 months |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Pediatrics East - Alabama Clinical Therapeutics | Pinson | Alabama | 35126 | 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 |
| Children's Research, LLC | Altamonte Springs | Florida | 32701 | United States |
| Deaconess Clinical Research | Evansville | Indiana | 47725 | United States |
| Heartland Research Associates, LLC | Augusta | Kansas | 67010 | United States |
| Heartland Research Associates, LLC | Newton | Kansas | 67114 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67205 | United States |
| Kentucky Pediatrics/Adult Research | Bardstown | Kentucky | 40004 | United States |
| Owensboro Pediatrics | Owensboro | Kentucky | 42303 | United States |
| Woburn Pediatic Associates | Woburn | Massachusetts | 01801 | 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 |