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The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Product | Experimental | Infant formula product consumed ad libitum as instructed for approximately 28 days; Powder formula mixed to 20 kcal/fl. oz. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrolyzed protein infant formula with oligosaccharides | Other | Hydrolyzed protein infant formula with oligosaccharides |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Maintenance | Change in weight for age z-score | Study Day1 to Study Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Tolerance | Parent completed diary | Study Day1 to Study Day 28 |
| Weight | Weight gain per day in grams | Study Day1 to Study Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Perspectives Questionnaire | Parent completed questionnaire; 4, 5-point Likert scale questions, scaled from negative to positive with higher scores indicating better perception | Study Day1 to Study Day 28 |
| Formula Satisfaction Questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlett Ramirez | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meridian Clinical Research, LLC | Washington D.C. | District of Columbia | 20016 | United States | ||
| AdventHealth Medical Group Pediatrics |
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| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Length | Length gain per day in cm | Study Day1 to Study Day 28 |
Parent completed questionnaire; 13 questions of up to 5 categories, scaled from positive to negative
| Study Day1 to Study Day 28 |
| Infant Feeding and Stool Patterns Questionnaire | Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from always to never | Study Day1 to Study Day 28 |
| Health Care Utilization | Number of Visits | Study Day1 to Study Day 28 |
| Adverse Events | Parent reported adverse events | Study Day1 to Study Day 28 |
| Orange City |
| Florida |
| 32763 |
| United States |
| Javara Inc. | Fayetteville | Georgia | 72703 | United States |
| Meridian Clinical Research 3259 | Macon | Georgia | 31210 | United States |
| Springs Medical Research | Owensboro | Kentucky | 42303 | United States |
| Meridian Clinical Research 3357 | Charleston | South Carolina | 29407 | United States |
| Gentle Pediatrics | Houston | Texas | 77084 | United States |