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Background Research suggests that fetal exposure to magnesium sulfate before preterm birth might reduce the risk of cerebral palsy.
Methods In this multicenter, placebo-controlled, double-blind trial, we randomly assigned women at imminent risk for delivery between 24 and 31 weeks of gestation to receive magnesium sulfate, administered intravenously as a 6-g bolus followed by a constant infusion of 2 g per hour, or matching placebo. The primary outcome was the composite of stillbirth or infant death by 1 year of corrected age or moderate or severe cerebral palsy at or beyond 2 years of corrected age.
Results A total of 2241 women underwent randomization. The baseline characteristics were similar in the two groups. Follow-up was achieved for 95.6% of the children. The rate of the primary outcome was not significantly different in the magnesium sulfate group and the placebo group (11.3% and 11.7%, respectively; relative risk, 0.97; 95% confidence interval [CI], 0.77 to 1.23). However, in a prespecified secondary analysis, moderate or severe cerebral palsy occurred significantly less frequently in the magnesium sulfate group (1.9% vs. 3.5%; relative risk, 0.55; 95% CI, 0.32 to 0.95). The risk of death did not differ significantly between the groups (9.5% vs. 8.5%; relative risk, 1.12; 95% CI, 0.85 to 1.47). No woman had a life-threatening event.
Conclusions Fetal exposure to magnesium sulfate before anticipated early preterm delivery did not reduce the combined risk of moderate or severe cerebral palsy or death, although the rate of cerebral palsy was reduced among survivors. (ClinicalTrials.gov number, NCT00014989
[ClinicalTrials.gov]
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Source Information
From the University of Alabama at Birmingham, Birmingham (D.J.R.); National Institute of Neurological Disorders and Stroke, Bethesda, MD (D.G.H.); George Washington University Biostatistics Center, Washington, DC (E.T.); University of Utah, Salt Lake City (M.W.V.); National Institute of Child Health and Human Development, Bethesda, MD (C.Y.S.); Case Western Reserve University, Cleveland, and University of Tennessee, Memphis (B.M.M.); Ohio State University, Columbus (J.D.I.); Thomas Jefferson University and Drexel University — both in Philadelphia (R.J.W.); Wayne State University, Detroit (Y.S.); University of Texas Southwestern Medical Center, Dallas (J.M.A.); Wake Forest University, Winston-Salem, NC (M.H.); University of North Carolina, Chapel Hill (J.M.T.); University of Texas at Houston, Houston (S.M.R.); Columbia University, New York (F.D.M.); Brown University, Providence, RI (M.C.); University of Cincinnati, Cincinnati (M.M.); University of Chicago, Chicago (A.M.); University of Miami, Miami (M.J.O.); Northwestern University, Chicago (A.M.P.); University of Texas Medical Branch, Galveston (G.D.V.H.); University of Texas at San Antonio, San Antonio (O.L.); and University of Pittsburgh, Pittsburgh (S.N.C., J.M.R.).
Address reprint requests to Dr. Rouse at OHB 457, 619 19th St. S., Birmingham, AL 35249-7333, or at drouse{at}uab.edu.
Related Letters:
Magnesium Sulfate for the Prevention of Cerebral Palsy
Mittendorf R., Pryde P. G., Rouse D. J., Hirtz D. G., Thom E. A., the Eunice Shriver Kennedy National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network
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N Engl J Med 2009;
360:189-190, Jan 8, 2009.
Correspondence
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