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

Pediatrics. 2009 May;123(5):e764-9. doi: 10.1542/peds.2007-3642. Epub 2009 Apr 6.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00553072.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Asphyxia Neonatorum / blood
  • Asphyxia Neonatorum / complications
  • Asphyxia Neonatorum / drug therapy*
  • Asphyxia Neonatorum / physiopathology
  • Brain Diseases / etiology
  • Calcium Channel Blockers / therapeutic use*
  • Female
  • Humans
  • Infant, Newborn
  • Magnesium / blood
  • Magnesium Sulfate / therapeutic use*
  • Male
  • Neurologic Examination
  • Neuroprotective Agents / therapeutic use
  • Prospective Studies

Substances

  • Calcium Channel Blockers
  • Neuroprotective Agents
  • Magnesium Sulfate
  • Magnesium

Associated data

  • ClinicalTrials.gov/NCT00553072