Growth and Tolerance of Cow's Milk-Based Infant Formulas

Mead Johnson Nutrition20 sites in 1 country373 target enrollmentJuly 2015

ConditionsGrowth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Growth
Sponsor: Mead Johnson Nutrition
Enrollment: 373
Locations: 20
Primary Endpoint: Body weight measured at each study visit
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

December 15, 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mead Johnson Nutrition

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Body weight measured at each study visit

Time Frame: 12 months

Measurement collected with a calibrated infant scale

Secondary Outcomes

Body length measured at each study visit(12 months)
Head circumference measured at each study visit(12 months)
Parental recall of study formula intake at each study visit(12 months)
Parental recall of stool consistency measured at each study visit(12 months)
Blood Collection(Once at 12 months)
Medically-confirmed adverse events collected throughout the study period(12 months)