Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, McGovern Medical School at UTHealth Houston, Houston, TX.
Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, McGovern Medical School at UTHealth Houston, Houston, TX.
Am J Obstet Gynecol. 2024 Dec;231(6):645.e1-645.e7. doi: 10.1016/j.ajog.2024.04.004. Epub 2024 Apr 7.
The recent paradigm shift of treating individuals at risk of late preterm birth with antenatal corticosteroids warrants an assessment of the effect of single dosage.
To compare outcomes of neonates born in the late preterm period (34.0-36.6 weeks) after a single dose of antenatal corticosteroids vs placebo.
We performed a secondary analysis of the Antenatal Late Preterm Steroids trial. All individuals enrolled in the parent trial who received only a single dose of either antenatal corticosteroids or placebo and delivered within 24 hours were included. Primary outcome was a composite of respiratory support at 72 hours, including continuous positive airway pressure or high-flow nasal cannula ≥2 hours, oxygen with an inspired fraction of ≥30% for ≥4 hours, or mechanical ventilation.
Of the 2831 individuals in the parent trial, 1083 (38.3%) met inclusion criteria; of them, 539 (49.8%) received a single dose of antenatal corticosteroids and 544 (50.2%) a single placebo dose. The placebo and antenatal corticosteroids groups had similar demographic and clinical characteristics. There was no difference in the rate of the primary respiratory outcome (adjusted risk ratio, 1.12; 95% confidence interval, 0.85-1.47) or in the rate of respiratory distress syndrome (adjusted risk ratio, 1.47; 95% confidence interval, 0.95-2.26) between those who received a single antenatal corticosteroids dose and placebo. An exploratory stratification by randomization-to-delivery intervals of 12-hour increments also showed no association with lower primary respiratory outcome rates.
In individuals with late preterm birth pregnancies who received antenatal corticosteroids and delivered before a second dose, there were no differences in neonatal respiratory morbidities compared with placebo. However, this study is not powered to detect treatment efficacy.
最近，将有早产风险的个体用产前皮质激素治疗的范式转变需要评估单次剂量的效果。
比较接受单次产前皮质激素与安慰剂治疗的晚期早产儿（34.0-36.6 周）新生儿的结局。
我们对产前晚期皮质激素试验进行了二次分析。所有在母体试验中只接受单次产前皮质激素或安慰剂治疗且在 24 小时内分娩的个体均被纳入。主要结局是 72 小时内呼吸支持的复合结局，包括持续气道正压通气或高流量鼻导管≥2 小时、吸入分数≥30%的氧气≥4 小时或机械通气。
在母体试验的 2831 名个体中，有 1083 名（38.3%）符合纳入标准；其中，539 名（49.8%）接受了单次产前皮质激素治疗，544 名（50.2%）接受了单次安慰剂治疗。安慰剂组和产前皮质激素组具有相似的人口统计学和临床特征。主要呼吸结局的发生率无差异（调整风险比，1.12；95%置信区间，0.85-1.47），也无呼吸窘迫综合征的发生率差异（调整风险比，1.47；95%置信区间，0.95-2.26）。对 12 小时递增的随机分组到分娩时间的分层分析也没有显示与较低的主要呼吸结局发生率相关。
在接受产前皮质激素治疗且在第二次剂量前分娩的晚期早产儿中，与安慰剂相比，新生儿呼吸并发症发生率无差异。然而，本研究没有足够的效力来检测治疗效果。
