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Clinical Trials/NCT00666120
NCT00666120
Completed
Not Applicable

Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula

Mead Johnson Nutrition18 sites in 1 country333 target enrollmentJune 2005
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ConditionsHealthy Term Infants Solely Formula Fed

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Term Infants Solely Formula Fed
Sponsor
Mead Johnson Nutrition
Enrollment
333
Locations
18
Primary Endpoint
Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator
Status
Completed
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2005
End Date
April 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mead Johnson Nutrition

Eligibility Criteria

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

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(60 days)

Study Sites (18)

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