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The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Human Milk Fortifier A | Active Comparator | Acidified processing method. |
|
| Study Human Milk Fortifier B | Experimental | Non-acidified processing method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Milk Fortifier A | Other | Acidified concentrated liquid human milk fortifier |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain | scale measurement g/kg/d | Study Day 1 to Study Day 29 (or discharge, whichever happens first) |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Tolerance | healthcare professional completed questionnaire | Study Day 1 to Study Day 29 (or discharge, whichever happens first) |
| Length | measured cm/wk |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bridget Barrett-Reis, PhD, RD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama Children's and Women's Hospital | Mobile | Alabama | 36604 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31975350 | Derived | Paul M, Partridge J, Barrett-Reis B, Ahmad KA, Machiraju P, Jayapalan H, Schanler RJ. Metabolic Acidosis in Preterm Infants is Associated with a Longer Length of Stay in the Neonatal Intensive Care Unit. Pharmacoecon Open. 2020 Sep;4(3):541-547. doi: 10.1007/s41669-020-00194-y. | |
| 30195561 | Derived | Schanler RJ, Groh-Wargo SL, Barrett-Reis B, White RD, Ahmad KA, Oliver J, Baggs G, Williams L, Adamkin D. Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier: A Prospective Randomized Clinical Trial. J Pediatr. 2018 Nov;202:31-37.e2. doi: 10.1016/j.jpeds.2018.07.005. Epub 2018 Sep 5. |
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| Human Milk Fortifier B | Other | Non-acidified concentrated liquid human milk fortifier |
|
| Study Day 1 to Study Day 29 (or discharge, whichever happens first) |
| Head Circumference | measured cm/wk | Study Day 1 to Study Day 29 (or discharge, whichever happens first) |
| Banner - University Medical Center Phoenix |
| Phoenix |
| Arizona |
| 85014 |
| United States |
| Yale University | New Haven | Connecticut | 06520-8064 | United States |
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| South Miami Hospital | Miami | Florida | 33143 | United States |
| All Children's Hospital / Johns Hopkins | St. Petersburg | Florida | 33701 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Cohen Children's Medical Center of NY at North Shore | Manhasset | New York | 11030 | United States |
| Cohen Children's Medical Center of NY | New Hyde Park | New York | 11040 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| Doctors Hospital at Renaissance/Women's Hospital at Renaissance | Edinburg | Texas | 78539 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Texas Health and Education Institute | Fort Worth | Texas | 76104 | United States |
| North Central Baptist Hospital | San Antonio | Texas | 78258 | United States |
| Wheaton Franciscan Heathcare Inc.- St. Joseph | Milwaukee | Wisconsin | 53210 | United States |