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The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Human Milk Fortifier | Experimental | Experimental human milk fortifier to be added to human milk |
|
| Control Human Milk Fortifier | Active Comparator | Control human milk fortifier to be added to human milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental human milk fortifier | Other | Human milk fortifier to be added to human milk feedings |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric variables | Length and head circumference | 29 days |
| GI tolerance | stool characteristics, periods of nil per os (NPO), and withheld feedings due to abdominal distention, gastric residuals, vomiting, etc. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bridget Barrett-Reis, PhD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35249-7335 | United States | ||
| UCSD Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26488118 | Derived | Kim JH, Chan G, Schanler R, Groh-Wargo S, Bloom B, Dimmit R, Williams L, Baggs G, Barrett-Reis B. Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier. J Pediatr Gastroenterol Nutr. 2015 Dec;61(6):665-71. doi: 10.1097/MPG.0000000000001010. |
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| Control human milk fortifier | Other | Control human milk fortifier to be added to human milk |
|
| 29 days |
| San Diego |
| California |
| 92103-8774 |
| United States |
| University South Florida | Tampa | Florida | 33606 | United States |
| Memorial Hospital of Southbend | Southbend | Indiana | 46601 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| King's County Hospital Center | Brooklyn | New York | 11203 | United States |
| Cohen Children's Medical Center of New York at North Shore | Manhasset | New York | 11030 | United States |
| Cohen Children's Medical Center of NY at North Shore | New Hyde Park | New York | 11040 | United States |
| Childrens Hospital Westchester Medical Center | Valhalla | New York | 10595 | United States |
| University Hospitals Case Medical Center Rainbow Babies & Children's Hospital | Cleveland | Ohio | 44106 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Toledo Children's Hospital | Toledo | Ohio | 43606 | United States |
| OHSU | Portland | Oregon | 97239 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |