Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
Univ. Arkansas Medical Sciences
Little Rock, Arkansas, United States
UCLA Medical Center
Los Angeles, California, United States
Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE)
Time frame: 12 months
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University Florida Health
Gainesville, Florida, United States
Wolfson Children´s Hospital
Jacksonville, Florida, United States
UF Health Jacksonville
Jacksonville, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Wesley Medical Center
Wichita, Kansas, United States
Kings County Hospital Center
Brooklyn, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
...and 5 more locations