本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.4303

摘要内容如下：

重要性

产前晚期早产类固醇（Alps）试验改变了美国的临床实践，发现产前34至36周的倍他米松可降低短期新生儿呼吸系统发病率。然而，该试验还发现，服用倍他米松后新生儿低血糖的风险增加。这项随访研究的重点是晚期早产儿使用类固醇后的长期神经发育结果。

目的

评估晚期早产（34-36周）皮质类固醇给药是否影响儿童期神经发育结果。

设计、设置和参与者

对6岁或6岁以上的儿童进行前瞻性随访研究，这些儿童的父母参加了多中心随机临床试验，该试验在2011年至2016年参与母胎医学单位（MFMU）网络周期的13个中心进行。随访时间为2017-2022年。

曝光

12毫克倍他米松肌肉注射，间隔24小时，分两次给药。

主要成果和措施

这项随访研究的主要结果是，在差异能力量表第2版（DAS-II）中，一般概念能力得分低于85（-1 SD）。次要结果包括粗大运动功能分类系统水平和社会反应量表以及儿童行为检查表评分。对预先指定的已知与主要结果相关的变量进行多变量分析调整。敏感性分析使用逆概率加权，并对失访患者的结果进行建模。

结果

在2831名儿童中，1026名入组，949名（479名倍他米松，470名安慰剂）完成了DAS-II，中位年龄为7岁（IQR，6.6-7.6岁）。除了新生儿低血糖在倍他米松组中更常见外，两组的母亲、新生儿和儿童期特征相似。主要转归没有差异，即一般概念能力评分低于85分，倍他米松组为82分（17.1%），安慰剂组为87分（18.5%）（校正相对危险度:0.94；95%可信区间为0.73-1.22）。未观察到次要结果的差异。使用逆概率加权或将结果分配给失访儿童的敏感性分析也发现两组之间没有差异。

结论和相关性

在这项随机临床试验的随访研究中，对有晚期早产风险的人在产前给予皮质类固醇，最初显示可改善短期新生儿呼吸结局，但低血糖发生率增加，与6岁或以上儿童的不良神经发育结局无关。

英文原文如下：

Abstracts

Importance  The Antenatal Late Preterm Steroids (ALPS) trial changed clinical practice in the United States by finding that antenatal betamethasone at 34 to 36 weeks decreased short-term neonatal respiratory morbidity. However, the trial also found increased risk of neonatal hypoglycemia after betamethasone. This follow-up study focused on long-term neurodevelopmental outcomes after late preterm steroids.

Objective  To evaluate whether administration of late preterm (34-36 completed weeks) corticosteroids affected childhood neurodevelopmental outcomes.

Design, Setting, and Participants  Prospective follow-up study of children aged 6 years or older whose birthing parent had enrolled in the multicenter randomized clinical trial, conducted at 13 centers that participated in the Maternal-Fetal Medicine Units (MFMU) Network cycle from 2011-2016. Follow-up was from 2017-2022.

Exposure  Twelve milligrams of intramuscular betamethasone administered twice 24 hours apart.

Main Outcome and Measures  The primary outcome of this follow-up study was a General Conceptual Ability score less than 85 (-1 SD) on the Differential Ability Scales, 2nd Edition (DAS-II). Secondary outcomes included the Gross Motor Function Classification System level and Social Responsiveness Scale and Child Behavior Checklist scores. Multivariable analyses adjusted for prespecified variables known to be associated with the primary outcome. Sensitivity analyses used inverse probability weighting and also modeled the outcome for those lost to follow-up.

Results  Of 2831 children, 1026 enrolled and 949 (479 betamethasone, 470 placebo) completed the DAS-II at a median age of 7 years (IQR, 6.6-7.6 years). Maternal, neonatal, and childhood characteristics were similar between groups except that neonatal hypoglycemia was more common in the betamethasone group. There were no differences in the primary outcome, a general conceptual ability score less than 85, which occurred in 82 (17.1%) of the betamethasone vs 87 (18.5%) of the placebo group (adjusted relative risk, 0.94; 95% CI, 0.73-1.22). No differences in secondary outcomes were observed. Sensitivity analyses using inverse probability weighting or assigning outcomes to children lost to follow-up also found no differences between groups.

Conclusion and Relevance  In this follow-up study of a randomized clinical trial, administration of antenatal corticosteroids to persons at risk of late preterm delivery, originally shown to improve short-term neonatal respiratory outcomes but with an increased rate of hypoglycemia, was not associated with adverse childhood neurodevelopmental outcomes at age 6 years or older.

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