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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014