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The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new Amino Acid Formula to infants consuming a commercially available hypoallergenic formula over a period of 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amino Acid Formula | Experimental | Hypoallergenic baby formula |
|
| Amino Acid commercial formula | Active Comparator | Hypoallergenic commercial amino acid formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino Acid Formula | Other | Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain | Mean weight gain (g/day) from enrollment to 4 months of age | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| tolerance | Tolerance will be evaluated based on formula intake, stool characteristics, vomiting/spitting up and behavior from enrollment to 4 months. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Corkins, MD | Le Bonheur Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35205 | United States | ||
| Alabama Clinical Therapeutics/Southlake Pediatrics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33006765 | Derived | Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2. |
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| Amino Acid formula | Other | Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula |
|
| Birmingham |
| Alabama |
| 35244 |
| United States |
| Clinical Research Consortium Arizona | Phoenix | Arizona | 85004 | United States |
| Lutheran General Children's Hospital | Park Ridge | Illinois | 60068 | United States |
| Nassim, MCMonigle, Mescia and Associates | New Albany | Indiana | 47150 | United States |
| Bluegrass Clinical Research, Inc. | Louisville | Kentucky | 40291 | United States |
| Southwestern Medical Clinic | Niles | Michigan | 49120 | United States |
| Southwestern Medical Clinic | Stevensville | Michigan | 49127 | United States |
| Women's Clinic of Lincoln, P.C. | Lincoln | Nebraska | 68510 | United States |
| Blue Ridge Pediatric and Adolescent Medicine, Inc. | Boone | North Carolina | 28607 | United States |
| Haywood Pediatric and Adolescent Medicine Group, P.A. | Clyde | North Carolina | 28721 | United States |
| Tarheel Clinical Research | Raleigh | North Carolina | 27612 | United States |
| Ohio Pediatric Research Assn. | Dayton | Ohio | 45414 | United States |
| Institute of Clinical Research | Mayfield Heights | Ohio | 44124 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| Clinical Research Specialists of Utah, Inc | Spanish Fork | Utah | 84660 | United States |