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Followup of Infants Fed Non-routine Infant Formula

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ClinicalTrials.gov Identifier: NCT00665938
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : January 31, 2012
Sponsor:
Information provided by:
Mead Johnson Nutrition

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to compare physical development of infants fed one of three study formulas.

Condition or disease Intervention/treatment Phase
Healthy Other: Infant formula Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Study Start Date : October 2006
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: 1 Other: Infant formula

Arm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL)

Arm 2. partially hydrolyzed infant formula with probiotics

Arm 3. extensively hydrolyzed infant formula with probiotics

Other Name: No other names are applicable to the 3 intervention arms
Experimental: 2 Other: Infant formula

Arm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL)

Arm 2. partially hydrolyzed infant formula with probiotics

Arm 3. extensively hydrolyzed infant formula with probiotics

Other Name: No other names are applicable to the 3 intervention arms
Experimental: 3 Other: Infant formula

Arm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL)

Arm 2. partially hydrolyzed infant formula with probiotics

Arm 3. extensively hydrolyzed infant formula with probiotics

Other Name: No other names are applicable to the 3 intervention arms


Outcome Measures
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Primary Outcome Measures :
  1. Achieved weight [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Tolerance [ Time Frame: 1 year ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   4 Months to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Completed Study 3369-5

Exclusion Criteria:

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665938


Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Study Director: Deolinda Scalabrin, MD Mead Johnson Nutrition
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Kim Merkel, Mead Johnson
ClinicalTrials.gov Identifier: NCT00665938     History of Changes
Other Study ID Numbers: 3369-6
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Mead Johnson Nutrition:
Physical development