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This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Infant Formula | Active Comparator | Milk-based study product |
|
| Experimental Infant Formula | Experimental | Milk-based study product with oligosaccharides |
|
| Reference Group | No Intervention | Human milk-fed group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Infant Formula | Other | Ready to feed infant formula, feed ad libitum |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight gain per day | Day of life 14 to Day of life 119 |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Characteristics | Parent completed diary | Study Day 1 to Day of life 119 |
| Formula Tolerance | Parent completed diary | Study Day 1 to Day of life 119 |
| Measure | Description | Time Frame |
|---|---|---|
| Infant and Household Characteristics | Parent reported lifestyle and illness questions | Study Day 1 to Day of Life 119 |
| Infant Feeding and Stool Patterns Questionnaire | Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timberly Williams, PhD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates | Birmingham | Alabama | 35205 | United States | ||
| Southeastern Pediatric Associates |
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| Experimental Infant Formula |
| Other |
Ready to feed infant formula, feed ad libitum |
|
| Length | Length gain per day | Day of life 14 to Day of life 119 |
| Head Circumference (HC) | HC gain per day | Day of life 14 to Day of life 119 |
| Exit or Day of life 119 |
| Infant Behavior Questionnaire | Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled in the negative direction | Exit or Day of life 42 to Day of life 119 |
| Formula Satisfaction Questionnaire | Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction | Exit or Day of life 119 |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Visions Clinical Research | Tucson | Arizona | 85712 | United States |
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72212 | United States |
| TOPAZ Clinical Research, Inc. | Apopka | Florida | 32703 | United States |
| University Clinical Research-Deland, LLC dba Avail Clinical Research- West Volusia Pediatrics | DeLand | Florida | 32720 | United States |
| Children's Research, LLC | Lake Mary | Florida | 32746 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| Pediatric & Adult Research Center | Orlando | Florida | 32825 | United States |
| Asclepes Research Centers | Spring Hill | Florida | 34609 | United States |
| Score Physician Alliance, LLC | St. Petersburg | Florida | 33710 | United States |
| PAS Research, LLC | Tampa | Florida | 33613 | United States |
| Tekton Research | Chamblee | Georgia | 30341 | United States |
| Saltzer Health | Nampa | Idaho | 83686 | United States |
| Deaconess Clinic, Inc. | Evansville | Indiana | 47725 | United States |
| Springs Medical Research | Owensboro | Kentucky | 42303 | United States |
| Meridian Clinical Research 3080 | Baton Rouge | Louisiana | 70806 | United States |
| Meridan Clinical Research | Omaha | Nebraska | 68134 | United States |
| Wake Research - Clinical Research Center of Nevada | Las Vegas | Nevada | 89123 | United States |
| ClinOhio Research Services | Columbus | Ohio | 43213 | United States |
| Ohio Pediatric Research Association | Dayton | Ohio | 45414 | United States |
| PriMed Clinical Research | Dayton | Ohio | 45419 | United States |
| Institute of Clinical Research, LLC | Mentor | Ohio | 44060 | United States |
| The Cleveland Pediatric Research Center, LLC | Middleburg Heights | Ohio | 44130 | United States |
| Midsouth Center for Clinical Research | Memphis | Tennessee | 38116 | United States |
| Medical Research Center of Memphis | Memphis | Tennessee | 38120 | United States |
| Gadolin Research, LLC | Beaumont | Texas | 77702 | United States |
| Women's Hospital at Renaissance - Doctors Hospital at Renaissance | Edinburg | Texas | 78539 | United States |
| Mercury Clincial Research, Inc. | Houston | Texas | 77008 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | United States |
| Aspen Clinical Research LLC | Orem | Utah | 84058 | United States |
| MultiCare Institute for Research and Innovation | Tacoma | Washington | 98405 | United States |