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| Name | Class |
|---|---|
| Accelovance | INDUSTRY |
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The primary objective is to determine if the weight gain of healthy term infants fed a commercially available term infant formula supplemented with DHASCO® is similar to that of infants fed the same formula supplemented with a new product, DHASCO®-B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| infant formula with DHASCO | Active Comparator | standard infant formula with docosahexaenoic acid (DHA) |
|
| infant formula with DHASCO-B | Experimental | standard infant formula with DHA-B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infant formula with DHASCO | Other |
| ||
| infant formula with DHASCO-B |
| Measure | Description | Time Frame |
|---|---|---|
| weight gain (gm/day) | gm/day -calculated from the weight measured at enrollment subtracted from the weight measured at DOL 120 visit, divided by the number of days between the actual visits. | through day of life 120 |
| Measure | Description | Time Frame |
|---|---|---|
| length (cm) | Length in cm | through day of life 120 |
| head circumference (cm) | head circumference (cm) | through day of life 120 |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | AEs collected throughout the study | through day of life 120 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Claude Ashley, MD | Dothan | Alabama | 36305 | United States | ||
| JBRKIDS |
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| Other |
|
| fatty acid levels (wgt %) | red blood cell (RBC) levels of omega-3 and omega-6 fatty acids (wgt %) in a sample subset | at day of life 120 |
| Formula intake and tolerance | assessed by analyzing three-day dietary intake and tolerance forms | Day of life 30 and 120 |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Norwich Pediatric | Norwich | Connecticut | 06360 | United States |
| Score Physician Alliance | St. Petersburg | Florida | 33710 | United States |
| Atlantic Clinical Research | Wellington | Florida | 33414 | United States |
| Pedia Research | Newburgh | Indiana | 47630 | United States |
| Heartland Research | Wichita | Kansas | 67205 | United States |
| Stephen Kasparian | Fall River | Massachusetts | 02720 | United States |
| MCHRI | Lincoln | Nebraska | 68504 | United States |
| Ohio Pediatric Research | Dayton | Ohio | 45414 | 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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