Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins through approximately 12 months of age.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A routine cow's milk-based infant formula | Active Comparator | A routine cow's milk-based infant formula |
|
| A partially hydrolyzed cow's milk protein (PHP) infant formula | Experimental | A partially hydrolyzed cow's milk protein (PHP) infant formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cow's milk protein infant formula | Other | A routine cow's milk-based infant formula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of body weight gain | up to 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Body length | up to 365 days of age | |
| Head circumference | up to 365 days of age | |
| Growth Z scores |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven Wu, Medical Director | Mead Johnson Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Pediatric Associates | Birmingham | Alabama | 35205 | United States | ||
| Southeastern Pediatric Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41527066 | Derived | Fabrizio V, Abdelmagid SA, Bose A, Hale M, Hays EC, Hudson M, Hughes T, Leonard D, Rouse K, Sideri M, Walker J, Wampler JL, Yeiser M, Zhuang W, Wu SS. Partially hydrolyzed cow's milk protein formula with an added prebiotic is well-tolerated, safe, and supports age-appropriate growth in healthy term infants through one year of age: DBRCT. BMC Pediatr. 2026 Jan 13;26(1):250. doi: 10.1186/s12887-025-06454-2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Partially hydrolyzed protein infant formula | Other | A partially hydrolyzed cow's milk protein (PHP) infant formula |
|
weight-for-age
| up to 365 days of age |
| Growth Z scores | length-for-age | up to 365 days of age |
| Growth Z scores | head circumference-for-age | up to 365 days of age |
| Recall of study formula intake measured at each study visit | questionnaire | up to 365 days of age |
| Recall of stool characteristics measured at each study visit | questionnaire | up to 365 days of age |
| Pediatric Quality of Life Family Impact Module | questionnaire | up to 365 days of age |
| Pediatric Quality of Life Inventory Infant Scales | Questionnaire. A 5-point response scale is utilized (0 = never a problem; 4 = always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better functioning (less negative impact). | 120, 180, 275, and 365 days of age |
| Medically confirmed adverse events collected throughout the study period | up to 365 days of age |
| Specific medically confirmed adverse events related to gastrointestinal | up to 365 days of age |
| Specific medically confirmed adverse events related to allergy | up to 365 days of age |
| Body weight | up to 365 days of age |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Visions Clinical Research-Tucson | Tucson | Arizona | 85712 | United States |
| Northwest Arkansas Pediatric Clinic | Fayetteville | Arkansas | 72703 | United States |
| The Children's Clinic of Jonesboro | Jonesboro | Arkansas | 72401 | United States |
| PAS Research | Tampa | Florida | 33613 | United States |
| Rophe Adult & Pediatric Medicine | Union City | Georgia | 30339 | United States |
| Saltzer Health | Nampa | Idaho | 83686 | United States |
| Springs Medical Research | Owensboro | Kentucky | 42303 | United States |
| Meridian Clinical Research | Grand Island | Nebraska | 68803 | United States |
| The Jackson Clinic | Jackson | Tennessee | 38305 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | United States |
| PAS Research | McAllen | Texas | 78501 | United States |