Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula

Mead Johnson Nutrition333 enrolled

Overview

To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator. Hypothesize there will be no difference between formula groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

333

Conditions

Healthy Term Infants Solely Formula Fed

Interventions

Enfamil LIPIL with ironOTHER

cow's milk based infant formula

Good Start Supreme with DHA and ARAOTHER

partially hydrolzed cow's milk protein

Eligibility

Sex: ALLMin age: 4 DaysMax age: 18 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Singleton birth * Term infant at birth * Birth weight of 2500 g (5 lbs 8 oz) or more * 4 - 18 days of age at Study Visit 1 Exclusion Criteria: * History of underlying metabolic or chronic disease or congenital malformation * Infant switched formulas more than one time between birth and Study Visit 1 * Known feeding problems at Study Visit 1

Locations (18)

Harvey Pediatrics

Jonesboro, Arkansas, United States

Mercy Rogers Pediatric Clinic

Rogers, Arkansas, United States

Outcomes

Primary Outcomes

Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator

Time frame: 60 days

Secondary Outcomes

Infant temperament

Time frame: 60 days

Data from ClinicalTrials.gov

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