Magnesium sulfate in severe perinatal asphyxia: a randomized, placebo-controlled trial.

OBJECTIVE: The goal was to study whether postnatal magnesium sulfate infusion could improve neurologic outcomes at discharge for term neonates with severe perinatal asphyxia.
METHODS: Forty term (> or =37 weeks of gestation) neonates with severe perinatal asphyxia were studied in a prospective, longitudinal, placebo-controlled trial. Patients were assigned randomly to receive either 3 doses of magnesium sulfate infusion at 250 mg/kg per dose (1 mL/kg per dose) 24 hours apart (treatment group) or 3 doses of normal saline infusion (1 mL/kg per dose) 24 hours apart (placebo group). Both groups also received supportive care according to the unit protocol for perinatal asphyxia.
RESULTS: In the treatment group, moderate encephalopathy was present in 35% (7 of 20) of the patients and severe encephalopathy in 65% (13 of 20) of patients at admission. In the placebo group, 40% (8 of 20) of patients had moderate encephalopathy and 60% (12 of 20) of patients had severe encephalopathy. The mean serum magnesium concentration in the treatment group remained at > or =1.2 mmol/L for 72 hours after the first infusion. At discharge, 22% (4 of 18) of infants in the treatment group had neurologic abnormalities, compared with 56% (10 of 18) of infants in the placebo group. Also, neuroimaging (head computed tomography) performed on day 14 yielded abnormal findings for fewer infants in the treatment group than in the placebo group (16% vs 44%). Infants in the treatment group were more likely to be receiving oral feedings (sucking) at discharge than were those in the placebo group (77% vs 37%). Good short-term outcomes at discharge occurred for 77% of the patients in the treatment group, compared with 37% of the patients in the placebo group.
CONCLUSION: Postnatal magnesium sulfate treatment improves neurologic outcomes at discharge for term neonates with severe perinatal asphyxia.

RCT Entities:   Population Interventions Outcomes