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Feeding Study in Premature Infants

This study has been completed.
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT00681018
First received: May 15, 2008
Last updated: August 30, 2010
Last verified: August 2010
History of Changes
  Purpose

To evaluate weight gain of preterm infants fed fortified human milk.


Condition Intervention
Premature Infants
 Other: Liquid human milk fortifier
Other: Powder human milk fortifier

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Feeding Study in Premature Infants

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Weight gain [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Feeding tolerance [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 143
Study Start Date: September 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Liquid human milk fortifier
 Other: Liquid human milk fortifier
Liquid human milk fortifier added to human milk
Other Name: No other names -- experimental product
Active Comparator: 2
Powder human milk fortifier
 Other: Powder human milk fortifier
Powder human milk fortifier added to human milk
Other Name: Enfamil Human Milk Fortifier

  Eligibility

Ages Eligible for Study:   up to 40 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • premature infant
  • birth weight less than/equal to 1250 g
  • exclusively breast fed

Exclusion Criteria:

  • metabolic or chronic disease
  • major surgery
  • ventilator dependent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681018

Locations
United States, Arkansas
The University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Florida
University of Florida
Jacksonville, Florida, United States, 32207
University of Florida
Jacksonville, Florida, United States, 32209
Plantation General Hospital
Plantation, Florida, United States, 33317
All Children's Hospital
St. Petersburg, Florida, United States, 33701
United States, Illinois
Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
Advocate Lutheran General Children's Hospital
Park Ridge, Illinois, United States, 60068
United States, Nebraska
Children's Hospital
Omaha, Nebraska, United States, 68114
United States, New York
Queen's Hospital
Jamaica, New York, United States, 11432
United States, North Carolina
Pitt County Memorial Hospital
Greenville, North Carolina, United States, 27834
SEAHEC
Wilmington, North Carolina, United States, 28402
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Virginia
Fairfax Hospital
Falls Church, Virginia, United States, 22046
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Study Director: Carol Lynn Berseth, MD Mead Johnson Nutrition
  More Information

No publications provided

Responsible Party: Carol Lynn Berseth, M.D., Mead Johnson
ClinicalTrials.gov Identifier: NCT00681018     History of Changes
Other Study ID Numbers: 3379-1
Study First Received: May 15, 2008
Last Updated: August 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Mead Johnson Nutrition:
premature
infants

ClinicalTrials.gov processed this record on May 19, 2013