Growth
Conditions
Brief summary
This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.
Interventions
OTHERMarketed cow's milk-based infant formula
OTHERCow's milk-based infant formula with added nutrients
Sponsors
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Singleton 10-14 days of age at randomization * Term infant with birth weight of minimum of 2500 grams * Solely formula fed * Signed informed consent and protected health information
Exclusion criteria
* History of underlying metabolic or chronic disease, anemia, or immune compromise * Feeding difficulties or formula intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of body weight gain from 14 to 120 days of age | 3.5 months |
Secondary
| Measure | Time frame |
|---|---|
| Recall of gastrointestinal tolerance questionnaire at each study visit | Up to 3.5 months |
| Medically confirmed adverse events collected throughout the study period | Up to 3.5 months |
| Head circumference measured at each study visit | Up to 3.5 months |
| Body length measured at each study visit | Up to 3.5 months |
| Recall of stool characteristics questionnaire measured at each study visit | Up to 3.5 months |
| Recall of infant formula at each study visit | Up to 3.5 months |
Countries
United States
Outcome results
None listed