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Feeding Study in Premature Infants

Sponsor
Mead Johnson Nutrition (Industry)
Overall Status
Completed
CT.gov ID
NCT00681018
Collaborator
(none)
143
Enrollment
14
Locations
2
Arms
23
Duration (Months)
10.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Liquid human milk fortifier
  • Other: Powder human milk fortifier
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
143 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Feeding Study in Premature Infants
Study Start Date :
Sep 1, 2008
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Liquid human milk fortifier

Other: Liquid human milk fortifier
Liquid human milk fortifier added to human milk
Other Names:
  • 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 Names:
  • Enfamil Human Milk Fortifier

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Weight gain [28 days]

    Secondary Outcome Measures

    1. Feeding tolerance [28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 40 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 The University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    2 University of Florida Jacksonville Florida United States 32207
    3 University of Florida Jacksonville Florida United States 32209
    4 Plantation General Hospital Plantation Florida United States 33317
    5 All Children's Hospital St. Petersburg Florida United States 33701
    6 Advocate Hope Children's Hospital Oak Lawn Illinois United States 60453
    7 Advocate Lutheran General Children's Hospital Park Ridge Illinois United States 60068
    8 Children's Hospital Omaha Nebraska United States 68114
    9 Queen's Hospital Jamaica New York United States 11432
    10 Pitt County Memorial Hospital Greenville North Carolina United States 27834
    11 SEAHEC Wilmington North Carolina United States 28402
    12 Forsyth Medical Center Winston-Salem North Carolina United States 27103
    13 Fairfax Hospital Falls Church Virginia United States 22046
    14 Virginia Commonwealth University Richmond Virginia United States 23298

    Sponsors and Collaborators

    • Mead Johnson Nutrition

    Investigators

    • Study Director: Carol Lynn Berseth, MD, Mead Johnson Nutrition

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00681018
    Other Study ID Numbers:
    • 3379-1
    First Posted:
    May 20, 2008
    Last Update Posted:
    Aug 31, 2010
    Last Verified:
    Aug 1, 2010
    Keywords provided by , ,
    premature
    infants
    Additional relevant MeSH terms:
    Premature Birth

    Study Results

    No Results Posted as of Aug 31, 2010