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| Name | Class |
|---|---|
| University of Kansas Medical Center | OTHER |
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The study is intended to measure infant comfort, behavior, and sleep when consuming study formula with prebiotics compared to infants who consume a study formula without the prebiotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previously marketed cow's milk-based infant formula | Active Comparator |
| |
| Marketed cow's milk-based infant formula with prebiotics | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Previously marketed cow's mlik-based infant formula | Other |
| ||
| Marketed cow's milk-based infant formula with prebiotics |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Measures (Amount of time awake and asleep in a 72 hour period) | 14 weeks | |
| Infant State (Infant behavior over a 72 hour period) | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Achieved Weight | Total weight gain | 14 weeks |
| Achieved Length | Total length gain | 14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol Lynn Berseth, MD | Mead Johnson Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Arkansas Pediatric Clinic | Fayetteville | Arkansas | 72703 | United States | ||
| Norwich Pediatrics |
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| Other |
|
| Achieved Head Circumference | Total head circumference gain | 14 weeks |
| Formula Intake | 14 weeks |
| Fecal microbiome | Baseline and 112 days of age |
| Medically-confirmed Adverse Events | 14 weeks |
| Salivary Cortisol levels | 70 and 120 days of age |
| Temperament - Infant Behavior Questionnaire | Once at 112 days of age |
| Sleep Characteristics | Amount of waking and sleeping, number of waking and sleep episodes | 14 weeks |
| Norwich |
| Connecticut |
| 06360 |
| United States |
| Deaconess Clinic | Evansville | Indiana | 47725 | United States |
| Universty of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Woburn Pediatrics | Woburn | Massachusetts | 01801 | United States |
| Pediatric Associates of Mt. Carmel | Cincinnati | Ohio | 45245 | United States |
| The Jackson Clinic | Jackson | Tennessee | 38305 | United States |
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |
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