Followup of Infants Fed Non-routine Infant Formula
This study has been completed.
Sponsor:
Mead Johnson Nutrition
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT00665938
First received: March 28, 2008
Last updated: January 27, 2012
Last verified: January 2012
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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
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 February 27, 2015