Feeding Study in Premature Infants

August 30, 2010 updated by: Mead Johnson Nutrition
To evaluate weight gain of preterm infants fed fortified human milk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

143

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • The University of Arkansas for Medical Sciences
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida
      • Jacksonville, Florida, United States, 32207
        • University of Florida
      • Plantation, Florida, United States, 33317
        • Plantation General Hospital
      • St. Petersburg, Florida, United States, 33701
        • All Children's Hospital
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Hope Children's Hospital
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Children's Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Children's Hospital
    • New York
      • Jamaica, New York, United States, 11432
        • Queen's Hospital
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Pitt County Memorial Hospital
      • Wilmington, North Carolina, United States, 28402
        • SEAHEC
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center
    • Virginia
      • Falls Church, Virginia, United States, 22046
        • Fairfax Hospital
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight gain
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Feeding tolerance
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

May 15, 2008

First Submitted That Met QC Criteria

May 19, 2008

First Posted (ESTIMATE)

May 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 31, 2010

Last Update Submitted That Met QC Criteria

August 30, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3379-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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