Preventing adverse outcomes of neonatal hypoxic ischaemic encephalopathy with erythropoeitin: A randomised controlled multicentre Australian trial.
Funding: NHMRC project grant APP1064294 (2014-2019), $2,010,583.
Chief Investigators: H Liley, R Hunt, S Jacobs, N Badawi, I Novak, L Askie, M Battin, R O'Connell.
Title: Preventing Adverse Outcomes of Neoantal Hypoxic Ischaemic Encephalopathy with Erythropoeitin: A Randomised Controlled Multicentre Australian Trial.
Rationale: Birth asphyxia and the hypoxic-ischaemic encephalopathy (HIE) causes significant neonatal mortality and disability worldwide. Even with hypothermia, 46% of term infants with moderate to severe HIE will die or survive with major neurodevelopmental disability. There is an urgent need for additional therapies, to reduce the rate and severity of impairment.
Design: Phase III RCT multi-centre trial to determine whether EPO plus hypothermia improves outcomes following HIE at 2 years, compared to hypothermia alone. Sample able to detect 19% absolute risk reduction in the combined endpoint of death or moderate-severe motor/cognitive deficit (80% power, p<0.05).
Update: Site approval for 5/20 centres and the EPO study drug and placebo is ready for dispatch. Early results from our USA collaborator, Prof Wu, indicate good safety margins in the first 50 infused, with 1yr follow-up data pending.
New knowledge: Erythropoietin (EPO) has neuroprotective effects that are distinct from hypothermia and may be additive in combination.
See more on trial information at the Clinical Trial website
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