Gampaha

Neonatal encephalopathy causes significant death and lifelong disabilities in babies born in low and middle-income countries (LMICs). Traditional cooling therapy used in high-income countries is not easily applicable or safe in LMICs. Erythropoietin (Epo), a drug commonly used to treat anemia, shows promise as a neuroprotective treatment for neonatal encephalopathy when used alone. Early studies suggest Epo may reduce death or disability without serious side effects, but a large, definitive trial is needed to confirm its safety and effectiveness in LMICs. This trial is a phase III, multi-country, double-blind study comparing Erythropoietin injections to placebo in babies with moderate or severe neonatal encephalopathy. Babies will receive nine doses of Epo at 500 units per kilogram, starting within six hours of birth and continuing daily for eight days. Alongside the drug treatment, all babies will receive supportive neonatal intensive care, including temperature monitoring to maintain normal body temperature and clinical support as needed. Participants will be closely monitored throughout the study, with brain imaging performed between one to two weeks of age to assess neurological effects. The primary outcome measured is the number of babies who die or survive with moderate or severe disability at 18 to 22 months. The trial includes an 18-month recruitment period, 18-month follow-up, and five months for data analysis, with a pilot phase conducted before the main trial begins.