Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
This study has been completed.
Sponsor:
Mead Johnson Nutrition
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT00666120
First received: April 22, 2008
Last updated: April 23, 2008
Last verified: April 2008
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Purpose
To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator.
Hypothesize there will be no difference between formula groups.
| Condition | Intervention |
|---|---|
|
Healthy Term Infants Solely Formula Fed |
Other: Enfamil LIPIL with iron Other: Good Start Supreme with DHA and ARA |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula |
Resource links provided by NLM:
Further study details as provided by Mead Johnson Nutrition:
Primary Outcome Measures:
- Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Infant temperament [ Time Frame: 60 days ] [ Designated as safety issue: No ]
| Enrollment: | 333 |
| Study Start Date: | June 2005 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Cow's milk based infant formula
|
Other: Enfamil LIPIL with iron
cow's milk based infant formula
|
|
Active Comparator: 2
Partially hydrolyzed cow's milk based infant formula
|
Other: Good Start Supreme with DHA and ARA
partially hydrolzed cow's milk protein
|
Eligibility| Ages Eligible for Study: | up to 18 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Singleton birth
- Term infant at birth
- Birth weight of 2500 g (5 lbs 8 oz) or more
- 4 - 18 days of age at Study Visit 1
Exclusion Criteria:
- History of underlying metabolic or chronic disease or congenital malformation
- Infant switched formulas more than one time between birth and Study Visit 1
- Known feeding problems at Study Visit 1
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666120
Locations
| United States, Arkansas | |
| Harvey Pediatrics | |
| Jonesboro, Arkansas, United States, 22401 | |
| Mercy Rogers Pediatric Clinic | |
| Rogers, Arkansas, United States, 72756 | |
| United States, California | |
| Lovelace Scientific Resources | |
| Santa Ana, California, United States, 92704 | |
| United States, Florida | |
| Tampa Bay Medical Research | |
| Clearwater, Florida, United States, 33761 | |
| Children's Medical Association | |
| Tamarac, Florida, United States, 33321 | |
| United States, Illinois | |
| Children's Health Care | |
| DeKalb, Illinois, United States, 60115 | |
| United States, Indiana | |
| Welborn Clinic | |
| Evansville, Indiana, United States, 47714 | |
| United States, Iowa | |
| Fomon Infant Nutrition Unit | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Heartland Research Associates | |
| Wichita, Kansas, United States, 67207 | |
| United States, Kentucky | |
| Pediatrics Clinical Trials Unit | |
| Louisville, Kentucky, United States, 40202 | |
| Pedia Research | |
| Owensboro, Kentucky, United States, 42301 | |
| United States, Louisiana | |
| Arklatex Children's Center | |
| Bossier City, Louisiana, United States, 71111 | |
| United States, Missouri | |
| Craig Spiegel, MD | |
| Bridgeton, Missouri, United States, 63044 | |
| United States, Nebraska | |
| The Center for Human Nutrition | |
| Omaha, Nebraska, United States, 68105 | |
| Boystown | |
| Omaha, Nebraska, United States, 68124 | |
| United States, New York | |
| Winthrop Pediatric Associates | |
| Mineola, New York, United States, 11501 | |
| United States, North Carolina | |
| Cary Pediatric Center | |
| Cary, North Carolina, United States, 27511 | |
| United States, Texas | |
| Collom and Carney Clinic | |
| Texarkana, Texas, United States, 75503 | |
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
| Study Director: | Carol Berseth, MD | Mead Johnson Nutrition |
More Information
No publications provided by Mead Johnson Nutrition
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Carol Lynn Berseth, M.D., Mead Johnson |
| ClinicalTrials.gov Identifier: | NCT00666120 History of Changes |
| Other Study ID Numbers: | 3370-6 |
| Study First Received: | April 22, 2008 |
| Last Updated: | April 23, 2008 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 21, 2013