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To compare the tolerance and early bone status of healthy, term infants fed formulas during the first three months of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protein formula | Experimental | Feed as per HCP direction |
|
| Standard infant formula | Active Comparator | Feed as per HCP instructions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alternate protein infant formula | Other | Feed as per HCP directions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean rank stool consistency at 14 days of age | 14 days of age |
| Measure | Description | Time Frame |
|---|---|---|
| Blood chemistries, bone mineral content, percent of feedings with spit-up or vomit associated with feeding | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlene W Borschel, PhD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Children's Health Research Institute | Lincoln | Nebraska | 68505 | United States | ||
| Children's Nutrition Research Center, Baylor College of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37929831 | Derived | Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2. |
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| Standard infant formula |
| Other |
Feed as per HCP directions |
|
| Houston |
| Texas |
| 77030 |
| United States |