drugset / Trial / NCT00719407
Neonatal Erythropoietin in Asphyxiated Term Newborns
Phase 1
Completed
24 enrolled
University of California, San Francisco
Santa Clara Valley Health & Hospital System · collabThrasher Research Fund · collabUCSF Benioff Children's Hospital Oakland · collabUniversity of Washington · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-01
- Primary completion
- 2011-09
- Completion
- 2012-11
Publications
- Rogers EE, Bonifacio SL, Glass HC, Juul SE, Chang T, Mayock DE, Durand DJ, Song D, Barkovich AJ, Ballard RA, Wu YW. Erythropoietin and hypothermia for hypoxic-ischemic encephalopathy. Pediatr Neurol. 2014 Nov;51(5):657-62. doi: 10.1016/j.pediatrneurol.2014.08.010. Epub 2014 Aug 27.
- Shankaran S. Outcomes of hypoxic-ischemic encephalopathy in neonates treated with hypothermia. Clin Perinatol. 2014 Mar;41(1):149-59. doi: 10.1016/j.clp.2013.10.008.
- Wu YW, Bauer LA, Ballard RA, Ferriero DM, Glidden DV, Mayock DE, Chang T, Durand DJ, Song D, Bonifacio SL, Gonzalez FF, Glass HC, Juul SE. Erythropoietin for neuroprotection in neonatal encephalopathy: safety and pharmacokinetics. Pediatrics. 2012 Oct;130(4):683-91. doi: 10.1542/peds.2012-0498. Epub 2012 Sep 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | epoetin alfa | Protein / enzyme biologic | 250 iu/kg | Intravenous |
| Subject | epoetin alfa | Protein / enzyme biologic | 500 iu/kg | Intravenous |
| Subject | epoetin alfa | Protein / enzyme biologic | 1000 iu/kg | Intravenous |
| Subject | epoetin alfa | Protein / enzyme biologic | 2500 iu/kg | Intravenous |