This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
321
Banner - University Medical Center
Phoenix, Arizona, United States
UAMS Medical Center
Little Rock, Arkansas, United States
Connecticut Children's Medical Center
Weight
Weight gain per day
Time frame: Study Day 1 to Study Day 29 or Hospital Discharge if first
Length
Length gains per week
Time frame: Study Day 1 to Study Day 15 and Study Day 29
Length
Attained length in cm
Time frame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Head Circumference
Head circumference gains per week
Time frame: Study Day 1 to Study Day 15 and Study Day 29
Head Circumference (HC)
Attained HC in cm
Time frame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Weight
Attained weight in grams
Time frame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Weight
Weight gain per day
Time frame: Study Day 1 to Study Day 15
Stool Characteristics
Percent bloody, black, watery, or hard stools
Time frame: Study Day 1 to Study Day 29
Feeding Intolerance
Percent periods NPO, feedings withheld due to gastrointestinal intolerance
Time frame: Study Day 1 to Study Day 29
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Hartford, Connecticut, United States
South Miami Hospital
Miami, Florida, United States
AdventHealth
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Tufts Medical Center
Boston, Massachusetts, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
University of New Mexico Children's Hospital
Albuquerque, New Mexico, United States
North Shore University Hospital
Manhasset, New York, United States
...and 4 more locations
Full Enteral Feeds
Days to achieve full enteral feeds
Time frame: Study Day 1 to Study Day 29