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Followup of Infants Fed Non-routine Infant Formula

This study has been completed.
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT00665938
First received: March 28, 2008
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this study is to compare physical development of infants fed one of three study formulas.


Condition Intervention
Healthy
 Other: Infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Achieved weight [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerance [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 183
Study Start Date: October 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Months to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Completed Study 3369-5

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665938

Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Study Director: Deolinda Scalabrin, MD Mead Johnson Nutrition
  More Information

No publications provided

Responsible Party: Kim Merkel, Mead Johnson
ClinicalTrials.gov Identifier: NCT00665938     History of Changes
Other Study ID Numbers: 3369-6, 3369-6
Study First Received: March 28, 2008
Last Updated: January 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mead Johnson Nutrition:
Physical development

ClinicalTrials.gov processed this record on May 16, 2013