Feeding Study in Premature Infants

NCT ID: NCT00681018

Last Updated: 2010-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-08-31

Brief Summary

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

Detailed Description

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Conditions

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Premature Infants

Keywords

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premature infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Liquid human milk fortifier

Group Type EXPERIMENTAL

Liquid human milk fortifier

Intervention Type OTHER

Liquid human milk fortifier added to human milk

2

Powder human milk fortifier

Group Type ACTIVE_COMPARATOR

Powder human milk fortifier

Intervention Type OTHER

Powder human milk fortifier added to human milk

Interventions

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Liquid human milk fortifier

Liquid human milk fortifier added to human milk

Intervention Type OTHER

Powder human milk fortifier

Powder human milk fortifier added to human milk

Intervention Type OTHER

Other Intervention Names

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No other names -- experimental product Enfamil Human Milk Fortifier

Eligibility Criteria

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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
Maximum Eligible Age

40 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mead Johnson Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Mead Johnson

Principal Investigators

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Carol Lynn Berseth, MD

Role: STUDY_DIRECTOR

Mead Johnson Nutrition

Locations

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The University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

University of Florida

Jacksonville, Florida, United States

Site Status

University of Florida

Jacksonville, Florida, United States

Site Status

Plantation General Hospital

Plantation, Florida, United States

Site Status

All Children's Hospital

St. Petersburg, Florida, United States

Site Status

Advocate Hope Children's Hospital

Oak Lawn, Illinois, United States

Site Status

Advocate Lutheran General Children's Hospital

Park Ridge, Illinois, United States

Site Status

Children's Hospital

Omaha, Nebraska, United States

Site Status

Queen's Hospital

Jamaica, New York, United States

Site Status

Pitt County Memorial Hospital

Greenville, North Carolina, United States

Site Status

SEAHEC

Wilmington, North Carolina, United States

Site Status

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Fairfax Hospital

Falls Church, Virginia, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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3379-1

Identifier Type: -

Identifier Source: org_study_id