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The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Feeding Group | Active Comparator | Milk based product |
|
| Experimental Feeding Group | Experimental | Milk based product with oligosaccharides |
|
| Human Milk Reference Group | Other | Human Milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Infant Formula | Other | Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth | weight for age z-score | Study Day 1 to 6 Months of Age |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of respiratory infection between study groups | Adverse event reports | Study Day 1 to 24 Months of Age |
| Number of respiratory infection episodes between study groups | Adverse event reports |
| Measure | Description | Time Frame |
|---|---|---|
| Formula Satisfaction Questionnaire | Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled from positive to negative | 28 Days of Age to 6 Months of Age |
| Toddler Drink Satisfaction Questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Reverri, PhD, MS, RD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedPharmics, LLC 3192 | Phoenix | Arizona | 85015 | United States | ||
| HealthStar Research |
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| Control Toddler Drink | Other | ~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age |
|
| Experimental Infant Formula | Other | Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age |
|
| Experimental Toddler Drink | Other | ~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age |
|
| Human Milk | Other | Ad libitum or as instructed by HCP |
|
| Human Milk Supplemental Formula | Other | Ad libitum if consuming supplemented formula; feeding period up to 12 months of age |
|
| Human Milk Toddler Drink | Other | ~16 fl oz per day if providing supplemental nutrition other than HM; feeding period from 12 to 24 months of age |
|
| Study Day 1 to 24 Months of Age |
| Incidence of infection morbidity between study groups | Adverse event reports | Study Day 1 to 24 Months of Age |
| Number of episodes of infection morbidity between study groups | Adverse event reports | Study Day 1 to 24 Months of Age |
| Weight | Interval weight gain per day | Study Day 1 to 24 Months of Age |
| Length | Interval length gain per day | Study Day 1 to 24 Months of Age |
| Head Circumference | Interval head circumference gain per day | Study Day 1 to 24 Months of Age |
| Gastrointestinal Tolerance | Parent completed diary | Study Day 1 to 12 months of Age |
Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled from positive to negative
| 18 Months of Age to 24 Months of Age |
| Infant Feeding and Stool Patterns Questionnaire | Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from Always to Never | 28 Days of Age to 119 Days of Age] |
| Infant and Toddler Behavior Questionnaire | Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled from Always to Never | 119 Days of Age |
| Product Intake | Parent completed intake diary | Study Day 1 to 24 Months of Age |
| Dietary Intake | Parent completed 24-hour recall | 6 Months of Age to 24 Months of Age |
| Stool Sample | Microbiota characterization; Subset of subjects | Study Day 1 to 24 Months of Age |
| Bayley™-4 Scale of Infant & Toddler Development IV | Examiner rated assessment; Scores are totaled and compared to normative age group data and between groups; Subset of subjects | 12 Months of Age to 24 Months of Age |
| MacArthur Communicative Developmental Inventory (CDI)/Words and Gestures and CDI)/Words and Sentences | Parent completed questionnaire of Words and Gestures and Words and Sentences; Percentiles compared to normative group data and between groups | 12 Months of Age to 24 Months of Age |
| Modified Home Short Form | Parent completed questionnaire; 8 questions related to the home environment adapted from the HSF compared between groups | 6 Months of Age to 24 Months of Age] |
| Medications | Medication usage including frequency and reason for use | Study Day 1 to 24 Months of Age |
| Adverse Events | Parent reported adverse events | Study Day 1 to 24 Months of Age |
| Health Resource Utilization | Number of visits | Study Day 1 to 24 Months of Age |
| Missed Parental Work Days | Parent reported number of days | Study Day 1 to 24 Months of Age |
| Blood Collection | Blood Immune Markers; Subset of subjects | 6 and 24 Months of Age |
| Glenwood |
| Arkansas |
| 71943 |
| United States |
| HealthStar Research, LLC | Hot Springs | Arkansas | 71913 | United States |
| The Children's Clinic of Jonesboro, P.A. | Jonesboro | Arkansas | 72401 | United States |
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72019 | United States |
| Optumcare Colorado Springs, LLC | Colorado Springs | Colorado | 80922 | United States |
| Boeson Research 3266 | Grand Junction | Colorado | 81505 | United States |
| TOPAZ Clinical Research, Inc. | Apopka | Florida | 32703 | United States |
| Columbus Clinical Services, LLC. | Miami | Florida | 33125 | United States |
| Emerald Coast OBGYN Clinical Research | Panama City | Florida | 32405 | United States |
| ASCLEPES Research Centers | Spring Hill | Florida | 34609 | United States |
| Jedidiah Clinical Research | Tampa | Florida | 33617 | United States |
| Meridian Clinical Research 3259 | Macon | Georgia | 31210 | United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| Leavitt Clinical Research | Idaho Falls | Idaho | 83404 | United States |
| Qualmedica Research | Evansville | Indiana | 47715 | United States |
| Deaconess Clinic, Inc. | Evansville | Indiana | 47725 | United States |
| Qualmedica Research, LLC | Owensboro | Kentucky | 42301 | United States |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| MedPharmics, LLC 3343 | Covington | Louisiana | 70433 | United States |
| MedPharmics Research 3369 | Slidell | Louisiana | 70458 | United States |
| Boeson Research 3367 | Great Falls | Montana | 59405 | United States |
| Boeson Research 3265 | Kalispell | Montana | 59901 | United States |
| Boeson Research 3267 | Missoula | Montana | 59804 | United States |
| Meridian Clinical Research 3264 | Grand Island | Nebraska | 68803 | United States |
| Meridian Clinical Research 3263 | Hastings | Nebraska | 68901 | United States |
| Meridian Clinical Research 3304 | Lincoln | Nebraska | 68510 | United States |
| Alivation Research | Lincoln | Nebraska | 68526 | United States |
| University of Nebraska Medical Center 3315 | Omaha | Nebraska | 68117 | United States |
| University of Nebraska Medical Center 3314 | Omaha | Nebraska | 68131 | United States |
| Advantage Clinical Trials | The Bronx | New York | 10468 | United States |
| Ohio Pediatric Research Association | Dayton | Ohio | 45414 | United States |
| Tribe Clinical Research LLC 3313 | Greenville | South Carolina | 29607 | United States |
| Tribe Clinical Research LLC 3382 | Spartanburg | South Carolina | 29301 | United States |
| Coastal Pediatric Research | Summerville | South Carolina | 29486 | United States |
| Holston Medical Group 3301 | Bristol | Tennessee | 37620 | United States |
| Holston Medical Group 3046 | Kingsport | Tennessee | 37660 | United States |
| AVIATI Healthcare & Clinical Research | Memphis | Tennessee | 38115 | United States |
| Javara Inc. 3377 | Dallas | Texas | 75230 | United States |
| Maximos Ob/Gyn | League City | Texas | 77573 | United States |
| National Clinical Research, Inc | Richmond | Virginia | 23294 | United States |
| Multicare Health System - Rockwood Pediatrics | Spokane | Washington | 99202 | United States |
| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |
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