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This clinical trial will evaluate an investigational infant formula with an alternate source of DHA to determine if it provides normal growth and if it is well tolerated by term infants as compared to a marketed routine infant formula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infant formula containing an alternate source of DHA | Experimental |
| |
| Marketed routine infant formula | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control: Marketed routine infant formula | Other |
| ||
| An investigational infant formula containing an alternate source of DHA |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight measured at each study visit | 3.5 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Recall of infant formula intake at each study visit | 3.5 months | |
| Body length measured at each study visit | 3.5 months | |
| Recall of stool consistency measured at each study visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol Lynn Berseth, M.D. | Mead Johnson and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Pediatric Associates | Birmingham | Alabama | 35205 | United States | ||
| Greenvale Pediatrics - Hoover |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27914519 | Derived | Yeiser M, Harris CL, Kirchoff AL, Patterson AC, Wampler JL, Zissman EN, Berseth CL. Growth and tolerance of infants fed formula with a new algal source of docosahexaenoic acid: Double-blind, randomized, controlled trial. Prostaglandins Leukot Essent Fatty Acids. 2016 Dec;115:89-96. doi: 10.1016/j.plefa.2016.09.001. Epub 2016 Sep 29. |
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| Other |
|
| 3.5 months |
| Medically-confirmed adverse events collected throughout the study period | 3.5 months |
| Head circumference measured at each study visit | 3.5 months |
| Recall of gastrointestinal tolerance measured at each study visit | 3.5 months |
| Blood Collection | Blood Collection from a subset of participants to measure levels of fatty acids such as docosahexaenoic acid (DHA) and arachidonic acid (ARA). | Once at 120 days of age |
| Birmingham |
| Alabama |
| 35244 |
| United States |
| Southeastern Pediatric Association | 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, PC | Norwich | Connecticut | 06360 | United States |
| Children's Research, LLC | Altamonte Springs | Florida | 32701 | United States |
| Physician Care Clinical Research | Sarasota | Florida | 34239 | United States |
| Deaconess Clinical Research | Evansville | Indiana | 47725 | United States |
| Owensboro Pediatrics | Owensboro | Kentucky | 42303 | United States |
| Woburn Pediatic Associates | Woburn | Massachusetts | 01801 | United States |
| Cary Pediatric Center | Cary | North Carolina | 27511 | United States |
| Capital Pediatrics & Adolescent Center | Raleigh | North Carolina | 27609 | United States |
| Pediatric Associates of Mt. Carmel, Inc | Cincinnati | Ohio | 45245 | 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 |
| Austin Diagnostic Clinic | Austin | Texas | 78745 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | United States |