产前用硫酸镁治疗与安慰剂治疗对极早产儿学龄期结局的影响。

School-age outcomes of very preterm infants after antenatal treatment with magnesium sulfate vs placebo.

机构信息

Departments of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia2Paediatrics, University of Melbourne, Melbourne, Australia3The Royal Women's Hospital, Melbourne, Australia4Murdoch Childrens Research Institute, Melbourne, Australia.

Departments of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia2Paediatrics, University of Melbourne, Melbourne, Australia4Murdoch Childrens Research Institute, Melbourne, Australia.

出版信息

JAMA. 2014 Sep 17;312(11):1105-13. doi: 10.1001/jama.2014.11189.

DOI:10.1001/jama.2014.11189

PMID:25226476

Abstract

IMPORTANCE

Antenatal magnesium sulfate given to pregnant women at imminent risk of very preterm delivery reduces the risk of cerebral palsy in early childhood, although its effects into school age have not been reported from randomized trials.

OBJECTIVE

To determine the association between exposure to antenatal magnesium sulfate and neurological, cognitive, academic, and behavioral outcomes at school age.

DESIGN, SETTING, AND PARTICIPANTS: The ACTOMgSO4 was a randomized clinical trial conducted in 16 centers in Australia and New Zealand, comparing magnesium sulfate with placebo given to pregnant women (n = 535 magnesium; n = 527 placebo) for whom imminent birth was planned or expected before 30 weeks' gestation. Children who survived from the 14 centers who participated in the school-age follow-up (n = 443 magnesium; n = 424 placebo) were invited for an assessment at 6 to 11 years of age between 2005 and 2011.

MAIN OUTCOMES AND MEASURES

Mortality, cerebral palsy, motor function, IQ, basic academic skills, attention and executive function, behavior, growth, and functional outcomes. Main analyses were imputed for missing data.

RESULTS

Of the 1255 fetuses known to be alive at randomization, the mortality rate to school age was 14% (88/629) in the magnesium sulfate group and 18% (110/626) in the placebo group (risk ratio [RR], 0.80; 95% CI, 0.62-1.03, P = .08). Of 867 survivors available for follow-up, outcomes at school age (corrected age 6-11 years) were determined for 669 (77%). Comparing the magnesium sulfate and placebo groups revealed no statistically significant difference in proportions with cerebral palsy (23/295 [8%] and 21/314 [7%], respectively; odds ratio [OR], 1.26; 95% CI, 0.84-1.91; P = .27) or abnormal motor function (80/297 [27%] and 80/300 [27%], respectively; OR, 1.16; 95% CI, 0.88-1.52; P = .28). There was also little difference between groups on any of the cognitive, behavioral, growth, or functional outcomes.

CONCLUSIONS AND RELEVANCE

Magnesium sulfate given to pregnant women at imminent risk of birth before 30 weeks' gestation was not associated with neurological, cognitive, behavioral, growth, or functional outcomes in their children at school age, although a mortality advantage cannot be excluded. The lack of long-term benefit requires confirmation in additional studies.

TRIAL REGISTRATION

anzctr.org.au Identifier: ACTRN12606000252516.

摘要

重要性

在即将早产的孕妇中给予产前硫酸镁可降低儿童早期脑瘫的风险，但随机试验尚未报告其对学龄期的影响。

目的

确定产前使用硫酸镁与学龄期神经、认知、学业和行为结果之间的关系。

设计、地点和参与者：ACTOMgSO4 是一项在澳大利亚和新西兰的 16 个中心进行的随机临床试验，比较了计划或预期在 30 周前分娩的孕妇（n=535 例硫酸镁；n=527 例安慰剂）使用硫酸镁与安慰剂。参加学龄期随访的 14 个中心中有 443 例（硫酸镁组）和 424 例（安慰剂组）幸存下来的儿童，于 2005 年至 2011 年之间在 6 至 11 岁时接受评估。

主要结果和测量

死亡率、脑瘫、运动功能、智商、基本学业技能、注意力和执行功能、行为、生长和功能结果。主要分析对缺失数据进行了插补。

结果

在随机分组时已知存活的 1255 名胎儿中，硫酸镁组的死亡率为学龄期 14%（88/629），安慰剂组为 18%（110/626）（风险比[RR]，0.80；95%CI，0.62-1.03，P=0.08）。在 867 名可随访的幸存者中，有 669 名（77%）的在校年龄（校正年龄 6-11 岁）结果确定。将硫酸镁组和安慰剂组进行比较，脑瘫的比例没有统计学显著差异（分别为 23/295[8%]和 21/314[7%]；比值比[OR]，1.26；95%CI，0.84-1.91；P=0.27）或运动功能异常（分别为 80/297[27%]和 80/300[27%]；OR，1.16；95%CI，0.88-1.52；P=0.28）。两组在认知、行为、生长或功能结果方面也几乎没有差异。