Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula

April 23, 2008 updated by: Mead Johnson Nutrition

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

333

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 22401
        • Harvey Pediatrics
      • Rogers, Arkansas, United States, 72756
        • Mercy Rogers Pediatric Clinic
    • California
      • Santa Ana, California, United States, 92704
        • Lovelace Scientific Resources
    • Florida
      • Clearwater, Florida, United States, 33761
        • Tampa Bay Medical Research
      • Tamarac, Florida, United States, 33321
        • Children's Medical Association
    • Illinois
      • DeKalb, Illinois, United States, 60115
        • Children's Health Care
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Welborn Clinic
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Fomon Infant Nutrition Unit
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Pediatrics Clinical Trials Unit
      • Owensboro, Kentucky, United States, 42301
        • Pedia Research
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Arklatex Children's Center
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Craig Spiegel, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • The Center for Human Nutrition
      • Omaha, Nebraska, United States, 68124
        • Boystown
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop Pediatric Associates
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • Cary Pediatric Center
    • Texas
      • Texarkana, Texas, United States, 75503
        • Collom And Carney Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 days to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Cow's milk based infant formula
Other: Enfamil LIPIL with iron
cow's milk based infant formula
Active Comparator: 2
Partially hydrolyzed cow's milk based infant formula
Other: Good Start Supreme with DHA and ARA
partially hydrolzed cow's milk protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Infant temperament
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Investigators

  • Study Director: Carol Berseth, MD, Mead Johnson Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

April 22, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 24, 2008

Study Record Updates

Last Update Posted (Estimate)

April 24, 2008

Last Update Submitted That Met QC Criteria

April 23, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • 3370-6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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