Status:

COMPLETED

Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula

Lead Sponsor:

Mead Johnson Nutrition

Conditions:

Healthy Term Infants Solely Formula Fed

Eligibility:

All Genders

4-18 years

Phase:

NA

Brief Summary

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2006

Estimated Enrollment :

333 Patients enrolled

Trial Details

Trial ID

NCT00666120

Start Date

June 1 2005

End Date

April 1 2006

Last Update

April 24 2008

Active Locations (18)

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Page 1 of 5 (18 locations)

1

Harvey Pediatrics

Jonesboro, Arkansas, United States, 22401

2

Mercy Rogers Pediatric Clinic

Rogers, Arkansas, United States, 72756

3

Lovelace Scientific Resources

Santa Ana, California, United States, 92704

4

Tampa Bay Medical Research

Clearwater, Florida, United States, 33761