Followup of Infants Fed Non-routine Infant Formula

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00665938

First Posted: April 24, 2008

Last Update Posted: January 31, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Mead Johnson Nutrition

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: Triple (Participant, Care Provider, Investigator)

Resource links provided by NLM:

MedlinePlus related topics: Infant and Newborn Nutrition

U.S. FDA Resources

Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:

Achieved weight [ Time Frame: 5 years ]

Secondary Outcome Measures:

Tolerance [ Time Frame: 1 year ]


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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


Responsible Party:	Kim Merkel, Mead Johnson
ClinicalTrials.gov Identifier:	NCT00665938 History of Changes
Other Study ID Numbers:	3369-6
First Submitted:	March 28, 2008
First Posted:	April 24, 2008
Last Update Posted:	January 31, 2012
Last Verified:	January 2012

Keywords provided by Mead Johnson Nutrition:


Physical development

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