The Effects on Growth and Tolerance of Hypoallergenic Formulas Fed to Term Infants

Mead Johnson Nutrition24 sites in 1 country511 target enrollmentJuly 2011

ConditionsGrowth of Term Infants

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Growth of Term Infants
Sponsor: Mead Johnson Nutrition
Enrollment: 511
Locations: 24
Primary Endpoint: Body weight measured at each study visit
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

December 2012

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Mead Johnson Nutrition

Eligibility Criteria

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

Outcomes

Primary Outcomes

Body weight measured at each study visit

Time Frame: 3.5 months

Secondary Outcomes

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)