Full Text View
Tabular View
No Study Results Posted
Related Studies
Followup of Infants Fed Non-Routine Infant Formula
This study is ongoing, but not recruiting participants.
First Received: March 28, 2008   Last Updated: April 23, 2008   History of Changes
Sponsored by: Mead Johnson
Information provided by: Mead Johnson
ClinicalTrials.gov Identifier: NCT00665938
  Purpose

Compare physical development of infants fed one of three study formulas


Condition Intervention
Healthy
 Other: Infant formula

MedlinePlus related topics: Infant and Toddler Nutrition
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment

Further study details as provided by Mead Johnson:

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
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator 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
2: Experimental 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
3: Experimental 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

  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
Investigators
Study Director: Deolinda Scalabrin, MD Mead Johnson
  More Information

No publications provided

Responsible Party: Mead Johnson ( Kim Merkel )
Study ID Numbers: 3369-6, 3369-6
Study First Received: March 28, 2008
Last Updated: April 23, 2008
ClinicalTrials.gov Identifier: NCT00665938     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Mead Johnson:
Physical development

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on May 07, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services