Growth of Term Infants
Conditions
Brief summary
This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula.
Interventions
OTHERInfant formula
Sponsors
Mead Johnson Nutrition
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Days to 16 Days
Healthy volunteers
Yes
Inclusion criteria
* Singleton, 12-16 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
* History of underlying metabolic or chronic disease or immunocompromised * Feeding difficulties or formula intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight measured at each study visit | 3.5 months |
Secondary
| Measure | Time frame |
|---|---|
| Recall of infant formula intake at each study visit | 3.5 months |
| Body Length and Head Circumference measured at each study visit | 3.5 months |
| Recall of stool characteristics and tolerance at each study visit | 3.5 months |
| Medically-confirmed adverse events collected throughout the study period | 3.5 months |
| Parental Product Assessment Questionnaire completed at Study Visit 2 | once |
Countries
United States
Outcome results
None listed