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NCT00681018 Clinical Trial

Feeding Study in Premature Infants

Premature Infants Clinical Trial

Official title:
Feeding Study in Premature Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00681018
Other study ID # 3379-1
Secondary ID
Status Completed
Phase N/A
First received May 15, 2008
Last updated August 30, 2010
Start date September 2008
Est. completion date August 2010

Study information
Verified date August 2010
Source Mead Johnson Nutrition
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 143
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 40 Days
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Other:
• Liquid human milk fortifier
Liquid human milk fortifier added to human milk
• Powder human milk fortifier
Powder human milk fortifier added to human milk

Locations
Country Name City State
United States Fairfax Hospital Falls Church Virginia
United States Pitt County Memorial Hospital Greenville North Carolina
United States University of Florida Jacksonville Florida
United States University of Florida Jacksonville Florida
United States Queen's Hospital Jamaica New York
United States The University of Arkansas for Medical Sciences Little Rock Arkansas
United States Advocate Hope Children's Hospital Oak Lawn Illinois
United States Children's Hospital Omaha Nebraska
United States Advocate Lutheran General Children's Hospital Park Ridge Illinois
United States Plantation General Hospital Plantation Florida
United States Virginia Commonwealth University Richmond Virginia
United States All Children's Hospital St. Petersburg Florida
United States SEAHEC Wilmington North Carolina
United States Forsyth Medical Center Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight gain 28 days Yes
Secondary Feeding tolerance 28 days No
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