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

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
|
- Achieved weight [ Time Frame: 5 years ]
- Tolerance [ Time Frame: 1 year ]

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Ages Eligible for Study: | 4 Months to 4 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Completed Study 3369-5
Exclusion Criteria:

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
Study Director: | Deolinda Scalabrin, MD | Mead Johnson Nutrition |
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 |