Growth
Conditions
Brief summary
This clinical trial will evaluate the growth, tolerance, and iron status of infants who consume an investigational infant formula containing a nutrient-rich whey protein compared to a previously marketed infant formula.
Interventions
OTHERPreviously marketed infant formula
OTHERPreviously marketed formula using a similar protein
Sponsors
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 a minimum of 2500 grams * Solely formula fed * Signed Informed Consent and Protected Health Information
Exclusion criteria
* Anemia at time of birth * Current use of iron or iron-containing supplements * History of underlying metabolic or chronic disease or immunocompromised * Feeding difficulties or formula intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight measured at each study visit | 12 months | Measurement collected with a calibrated infant scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Head circumference measured at each study visit | 12 months | Measurement collected with a standardized measuring tape |
| Parental recall of study formula intake at each study visit | 12 months | — |
| Body length measured at each study visit | 12 months | Measurement collected with a standardized length board |
| Blood Collection | Once at 12 months | Composite measure of hemoglobin, hematocrit, ferritin, and c-reactive protein |
| Medically-confirmed adverse events collected throughout the study period | 12 months | — |
| Parental recall of stool consistency measured at each study visit | 12 months | — |
Countries
United States
Outcome results
None listed