Erythropoietin Monotherapy for Brain Regeneration in Neonatal Encephalopathy in Low and Middle-Income Countries

What this Trial Is About

Neonatal encephalopathy causes a high number of infant deaths and lifelong disabilities in low and middle-income countries. Unlike high-income countries where cooling therapy is used in intensive care, such treatment is rarely available in these regions due to resource limitations and safety concerns. Erythropoietin, a drug with neuroprotective and regenerative properties, has shown promise as a single therapy for newborns with this condition in smaller studies, supporting the need for a larger trial to evaluate its safety and effectiveness. This trial evaluates erythropoietin monotherapy compared with a placebo injection in newborns with moderate or severe neonatal encephalopathy in low and middle-income countries. Babies will receive intravenous or subcutaneous erythropoietin at a dose of 500 units per kilogram, starting within 6 hours of birth and continuing daily for a total of 9 doses over 8 days. The control group will receive mock injections. The trial includes monitoring and maintaining normal body temperature and uses brain imaging techniques between 1 to 2 weeks of age. Participants will be followed for 18 months after treatment to assess survival and disability outcomes. Researchers will collect data through clinical exams, brain scans, and hospital records to monitor neurological development, safety, and adverse events. The primary outcome is the number of babies who die or survive with moderate or severe disability by 18 to 22 months. The study includes an initial pilot phase and plans for data analysis after follow-up completion.

Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)