The purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.
Newborn infants with birth asphyxia are at high risk of death or long-term neurologic disability; yet therapies for birth asphyxia are currently limited. Erythropoietin (Epo) is a FDA-approved drug that is an effective neuroprotective agent in animal models of birth asphyxia. This is a phase I dose finding multi-center trial that will test the safety and pharmacokinetics of Epo in human infants with birth asphyxia. The long-term objectives of the proposed research are to reduce mortality and to decrease the risk of long-term disabilities in infants who survive beyond the newborn period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
250 U/kg/dose x 6 doses (n=3); 500 U/kg/dose x 6 doses (n=6); 1,000 U/kg/dose x 6 doses (n=7) 2,500 U/kg/dose x 6 doses (n=8)
University of California, San Francisco
San Francisco, California, United States
Serious adverse event
Time frame: 14 days of life
Pharmacokinetic parameters
Time frame: 1 to 11 days of life
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