Neonatal Erythropoietin in Asphyxiated Term Newborns (NEAT)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Neonatal Erythropoietin in Asphyxiated Term Newborns: a Phase I Trial|
- Serious adverse event [ Time Frame: 14 days of life ] [ Designated as safety issue: Yes ]
- Pharmacokinetic parameters [ Time Frame: 1 to 11 days of life ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
All enrolled patients will be in this single arm, who will receive experimental drug treatment.
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)
Other Name: Procrit
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719407
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Yvonne W Wu, MD, MPH||University of California, San Francisco|