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Feeding Study in Premature Infants

Primary Purpose

Premature Infants

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Liquid human milk fortifier
Powder human milk fortifier
Sponsored by
Mead Johnson Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Infants focused on measuring premature, infants

Eligibility Criteria

undefined - 40 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Arkansas for Medical Sciences
  • University of Florida
  • University of Florida
  • Plantation General Hospital
  • All Children's Hospital
  • Advocate Hope Children's Hospital
  • Advocate Lutheran General Children's Hospital
  • Children's Hospital
  • Queen's Hospital
  • Pitt County Memorial Hospital
  • SEAHEC
  • Forsyth Medical Center
  • Fairfax Hospital
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Liquid human milk fortifier

Powder human milk fortifier

Outcomes

Primary Outcome Measures

Weight gain

Secondary Outcome Measures

Feeding tolerance

Full Information

First Posted
May 15, 2008
Last Updated
August 30, 2010
Sponsor
Mead Johnson Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT00681018
Brief Title
Feeding Study in Premature Infants
Official Title
Feeding Study in Premature Infants
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mead Johnson Nutrition

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infants
Keywords
premature, infants

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Liquid human milk fortifier
Arm Title
2
Arm Type
Active Comparator
Arm Description
Powder human milk fortifier
Intervention Type
Other
Intervention Name(s)
Liquid human milk fortifier
Other Intervention Name(s)
No other names -- experimental product
Intervention Description
Liquid human milk fortifier added to human milk
Intervention Type
Other
Intervention Name(s)
Powder human milk fortifier
Other Intervention Name(s)
Enfamil Human Milk Fortifier
Intervention Description
Powder human milk fortifier added to human milk
Primary Outcome Measure Information:
Title
Weight gain
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Feeding tolerance
Time Frame
28 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
40 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Lynn Berseth, MD
Organizational Affiliation
Mead Johnson Nutrition
Official's Role
Study Director
Facility Information:
Facility Name
The University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Plantation General Hospital
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
All Children's Hospital
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Advocate Hope Children's Hospital
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Advocate Lutheran General Children's Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Children's Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Queen's Hospital
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Pitt County Memorial Hospital
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
SEAHEC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28402
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22046
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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Feeding Study in Premature Infants

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