A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy

被引：432

作者：

Rouse, Dwight J. ^{[1
]}

Hirtz, Deborah G. ^{[2
]}

Thom, Elizabeth ^{[3
]}

Varner, Michael W. ^{[4
]}

Spong, Catherine Y. ^{[5
]}

Mercer, Brian M. ^{[6
,7
]}

Iams, Jay D. ^{[8
]}

Wapner, Ronald J. ^{[9
,10
]}

Sorokin, Yoram ^{[11
]}

Alexander, James M. ^{[12
]}

Harper, Margaret ^{[13
]}

Thorp, John M., Jr. ^{[14
]}

Ramin, Susan M. ^{[15
]}

Malone, Fergal D. ^{[16
]}

Carpenter, Marshall ^{[17
]}

Miodovnik, Menachem ^{[18
]}

Moawad, Atef ^{[19
]}

O'Sullivan, Mary J. ^{[20
]}

Peaceman, Alan M. ^{[21
]}

Hankins, Gary D. V. ^{[22
]}

Langer, Oded ^{[23
]}

Caritis, Steve N. ^{[24
]}

Roberts, James M. ^{[24
]}

机构：

[1] Univ Alabama Birmingham, Birmingham, AL USA

[2] Natl Inst Neurol Disorders & Stroke, Bethesda, MD USA

[3] George Washington Univ, Ctr Biostat, Washington, DC USA

[4] Univ Utah, Salt Lake City, UT USA

[5] NICHHD, Bethesda, MD 20892 USA

[6] Case Western Reserve Univ, Cleveland, OH 44106 USA

[7] Univ Tennessee, Memphis, TN USA

[8] Ohio State Univ, Columbus, OH 43210 USA

[9] Thomas Jefferson Univ, Philadelphia, PA 19107 USA

[10] Drexel Univ, Philadelphia, PA 19104 USA

[11] Wayne State Univ, Detroit, MI USA

[12] Univ Texas Dallas, SW Med Ctr, Dallas, TX 75230 USA

[13] Wake Forest Univ, Winston Salem, NC 27109 USA

[14] Univ N Carolina, Chapel Hill, NC USA

[15] Univ Texas Houston, Houston, TX USA

[16] Columbia Univ, New York, NY USA

[17] Brown Univ, Providence, RI 02912 USA

[18] Univ Cincinnati, Cincinnati, OH USA

[19] Univ Chicago, Chicago, IL 60637 USA

[20] Univ Miami, Miami, FL USA

[21] Northwestern Univ, Chicago, IL 60611 USA

[22] Univ Texas Galveston, Med Branch, Galveston, TX 77550 USA

[23] Univ Texas San Antonio, San Antonio, TX USA

[24] Univ Pittsburgh, Pittsburgh, PA USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2008年 / 359卷 / 09期

关键词：

D O I：

10.1056/NEJMoa0801187

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.).

引用

页码：895 / 905

页数：11

共 35 条

[1] Proposed definition and classification of cerebral palsy, April 2005 - Introduction [J].