drugset / Trial / NCT03079167
PAEAN - Erythropoietin for Hypoxic Ischaemic Encephalopathy in Newborns
Phase 3
Completed
313 enrolled
University of Sydney
National Health and Medical Research Council, Australia · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Double-blind, placebo controlled Phase III trial of erythropoietin for hypoxic ischaemic encephalopathy in infants receiving hypothermia. The study aim is to determine whether Epo in conjunction with hypothermia in infants with moderate/severe hypoxic ischaemic encephalopathy (HIE) will improve neurodevelopmental outcomes at 2 years of age, without significant adverse effects, when compared to hypothermia alone.
Timeline
- Start
- 2016-05-14
- Primary completion
- 2023-11-30
- Completion
- 2024-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | epoetin alfa | Protein / enzyme biologic | 1000 iu/kg | Intravenous |