Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas

Mead Johnson Nutrition17 sites in 1 countryOctober 2016

ConditionsGrowth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Growth
Sponsor: Mead Johnson Nutrition
Locations: 17
Primary Endpoint: Rate of body weight gain from 14 to 120 days of age
Status: Withdrawn
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2016

End Date

April 2018

Last Updated

8 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 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

Outcomes

Primary Outcomes

Rate of body weight gain from 14 to 120 days of age

Time Frame: 3.5 months

Secondary Outcomes

Recall of infant formula at each study visit(Up to 3.5 months)
Body length measured 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)
Recall of stool characteristics questionnaire measured at each study visit(Up to 3.5 months)
Recall of gastrointestinal tolerance questionnaire at each study visit(Up to 3.5 months)