The use of erythropoietin and magnesium sulphate for the management of hypoxic-ischaemic encephalopathy in Lagos, Nigeria: A randomized control trial

Abstract

ABSTRACT Background: Therapeutic hypothermia is the recommended treatment for moderate-to-severe hypoxic-ischemic encephalopathy (HIE) in newborns. It is not readily available in low- and middle-income countries. Newer promising interventions include erythropoietin (EPO) and magnesium sulfate (MgSO 4 ). This study evaluated the short-term effects of EPO and MgSO4 in the management of term infants with severe perinatal asphyxia. Methods: This was a randomized control trial conducted in the neonatal wards of two tertiary hospitals in Lagos over a 2-year period. Term neonates diagnosed with moderate-to-severe HIE at admission were randomized to receive either EPO (34 infants), MgSO4 (45 infants), or placebo care according to the unit protocol (29 infants). Survivors were followed up for 2 years for neurodevelopmental delay. The neonatal outcomes of the participants were presented here. Descriptive statistics were employed to analyze data using Stata version 16. Results: There were 107 participants; 69% were males, and 76.6% were outborn. The mean gestational age and birthweight were 38.6 (±2.4) weeks and 3000 (±677) g, respectively. The mean age at intervention was 19.0 (10–30) h. Four neonates had HIE 1, 73, HIE 2, and 30 had HIE 3. Only 14 babies received intervention drugs within 6 h of birth. Thirty-eight (35.5%) neonates died. Survival was significantly higher in infants treated with MgSO4 (34/45, 75.6%) compared to the placebo group (14/28, 50.0%, P = 0.03) but not in the EPO group (21/34, 61.8%, P = 0.32). The MgSO4 group had a higher decline in the risk ratio (RR) of neurological abnormalities compared to placebo (AdjRR: 0.34, 95% CI: 0.09–0.93, P = 0.007). Conclusion: Neonates with HIE had a better short-term outcome when treated with MgSO4 compared to placebo.