Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula

This study has been completed.
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT00666120
First received: April 22, 2008
Last updated: April 23, 2008
Last verified: April 2008
  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
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: 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 September 29, 2014