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This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | |||
| Experimental 1 | |||
| Experimental 2 |
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| Measure | Description | Time Frame |
|---|---|---|
| Body weight measured on calibrated infant scale at each study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Twenty-four hour recall of infant formula intake at each study visit | ||
| Medically-confirmed adverse events collected throughout the study period | ||
| Twenty-four hour recall of stool characteristics (number and consistency) and tolerance at each study visit |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy, term infants
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Pediatric Associates | Birmingham | Alabama | 35205 | United States | ||
| Southeastern Pediatric Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26547414 | Derived | Johnston WH, Ashley C, Yeiser M, Harris CL, Stolz SI, Wampler JL, Wittke A, Cooper TR. Growth and tolerance of formula with lactoferrin in infants through one year of age: double-blind, randomized, controlled trial. BMC Pediatr. 2015 Nov 7;15:173. doi: 10.1186/s12887-015-0488-3. |
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| Parental Product Assessment Questionnaire completed at Study Visit 2 | Assessment of physical properties of product and infant's reaction during consumption. |
| Body Length and Head Circumference measured at each study visit |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Pediatrics East - Alabama Clinical Therapeutics | Pinson | Alabama | 35126 | United States |
| Central Arkansas Pediatric Clinic | Benton | Arkansas | 72019 | United States |
| Arkansas Pediatric Clinic | Little Rock | Arkansas | 72205 | United States |
| Norwich Pediatric Group, PC | Norwich | Connecticut | 06360 | United States |
| Altamonte Pediatric Associates | Lake Mary | Florida | 32746 | United States |
| Children's Medical Association | Plantation | Florida | 33324 | United States |
| North Georgia Clinical Research Center/White's Pediatrics | Dalton | Georgia | 30721 | United States |
| Deaconess Clinic Gateway | Newburgh | Indiana | 47630 | United States |
| PTCU/Children & Youth Project | Louisville | Kentucky | 40202 | United States |
| Owensboro Pediatrics | Owensboro | Kentucky | 42303 | United States |
| Woburn Pediatric Associates | Woburn | Massachusetts | 01801 | United States |
| Southwestern Medical Clinic, PC | Niles | Michigan | 49120 | United States |
| Southwestern Medical Clinic P.C. | Stevensville | Michigan | 49127 | United States |
| The Center for Human Nutrition | Omaha | Nebraska | 68105 | United States |
| Cary Pediatric Center, PA | Cary | North Carolina | 27511 | United States |
| Innovis Health South University | Fargo | North Dakota | 58103 | United States |
| Red Lion Pediatrics | Philadelphia | Pennsylvania | 19114 | United States |
| Primary Physicians Research, Inc | Pittsburgh | Pennsylvania | 15241 | United States |
| Alpha Clinical Research | Clarksville | Tennessee | 37043 | United States |
| The Jackson Clinic - North Jackson | Jackson | Tennessee | 38305 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Austin Diagnostic Clinic | Austin | Texas | 78745 | United States |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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