Feeding Study in Premature Infants
1 other identifier
interventional
143
1 country
14
Brief Summary
To evaluate weight gain of preterm infants fed fortified human milk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2008
Typical duration for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2008
CompletedFirst Posted
Study publicly available on registry
May 20, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedAugust 31, 2010
August 1, 2010
1.9 years
May 15, 2008
August 30, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight gain
28 days
Secondary Outcomes (1)
Feeding tolerance
28 days
Study Arms (2)
1
EXPERIMENTALLiquid human milk fortifier
2
ACTIVE COMPARATORPowder human milk fortifier
Interventions
Liquid human milk fortifier added to human milk
Powder human milk fortifier added to human milk
Eligibility Criteria
You may qualify if:
- premature infant
- birth weight less than/equal to 1250 g
- exclusively breast fed
You may not qualify if:
- metabolic or chronic disease
- major surgery
- ventilator dependent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
The University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
University of Florida
Jacksonville, Florida, 32207, United States
University of Florida
Jacksonville, Florida, 32209, United States
Plantation General Hospital
Plantation, Florida, 33317, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Advocate Hope Children's Hospital
Oak Lawn, Illinois, 60453, United States
Advocate Lutheran General Children's Hospital
Park Ridge, Illinois, 60068, United States
Children's Hospital
Omaha, Nebraska, 68114, United States
Queen's Hospital
Jamaica, New York, 11432, United States
Pitt County Memorial Hospital
Greenville, North Carolina, 27834, United States
SEAHEC
Wilmington, North Carolina, 28402, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Fairfax Hospital
Falls Church, Virginia, 22046, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carol Lynn Berseth, MD
Mead Johnson Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 15, 2008
First Posted
May 20, 2008
Study Start
September 1, 2008
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
August 31, 2010
Record last verified: 2010-08