Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)
Status:
Not yet recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
One million babies die, and at least 2 million survive with lifelong disabilities following
neonatal encephalopathy (NE) in low and middle-income countries (LMICs), every year. Cooling
therapy in the context of modern tertiary intensive care improves outcome after NE in
high-income countries. However, the uptake and applicability of cooling therapy in LMICs is
poor, due to the lack of intensive care and transport facilities to initiate and administer
the treatment within the six-hours window after birth as well as the absence of safety and
efficacy data on hypothermia for moderate or severe NE.
Erythropoietin (Epo) is a promising neuroprotectant with both acute effects
(anti-inflammatory, anti-excitotoxic, antioxidant, and antiapoptotic) and regenerative
effects (neurogenesis, angiogenesis, and oligodendrogenesis),which are essential for the
repair of injury and normal neurodevelopment. Pooled data from 5 small randomized clinical
trials (RCTs) (n=348 babies), suggests that Epo (without cooling therapy) reduce the risk of
death or disability at 3 months or more after NE (Risk Ratio 0.62 (95% CI 0.40 to 0.98).
Hence, a definitive trial (phase III) for rigorous evaluation of the safety and efficacy of
Epo monotherapy in LMIC is now warranted.