Clinical Trial: Neonatal Erythropoietin in Asphyxiated Term Newborns

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Neonatal Erythropoietin in Asphyxiated Term Newborns: a Phase I Trial

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of California, San Francisco

Current Primary Outcome: Serious adverse event [ Time Frame: 14 days of life ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Pharmacokinetic parameters [ Time Frame: 1 to 11 days of life ]

Original Secondary Outcome: Pharmacokinetic parameters [ Time Frame: 1 to 4 days of life ]

Information By: University of California, San Francisco

Dates:
Date Received: July 17, 2008
Date Started: January 2010
Date Completion:
Last Updated: November 7, 2012
Last Verified: November 2012