A randomized controlled trial on the use of magnesium sulfate and melatonin in neonatal hypoxic ischemic encephalopathy

Abstract.
BACKGROUND: Birth asphyxia is a leading case of neonatal morbidity and mortality especially in developing countries. Hypoxic-ischemic encephalopathy (HIE) attributed to asphyxia can be ameliorated with several remedies, although full recovery is currently not feasible. The aim of this trial on infants with HIE who are receiving melatonin therapy, is to assess the added effect of magnesium sulfate (MgSO4) on the expression of S100-B, a marker of brain injury.
METHODS: This study is a randomized controlled trial on neonates with moderate HIE (Sarnat grade II). Infants were randomized into 2 groups; group1 who received MgSO4 and melatonin; and group 2 who received melatonin only. Serum concentrations of S100-B were measured at baseline, and at days 2 and 6 of therapy.
RESULTS: The study included 60 neonates of them 30 infants in group 1 and 30 infants in group 2. S100-B did not differ between groups 1 and 2 at enrollment (median = 13.5 vs 13.2, p = 0.381). However, group 1 had lower concentrations of S100-B at 2 days (median = 8 vs 12, p = 0.001) and at 6 days (median = 3 vs 10.5, p < 0.001), respectively. Compared to baseline, S100-B decreased in in group 2 at day 6 (13.2 vs 10.5, p = 0.011) but did not decrease at day 2 (13.2 vs 12, p = 0.478).
CONCLUSIONS: MgSO4 may have an added effect for the reduction in brain injury in infants with HIE who are receiving melatonin.