Mid-Childhood Outcomes of Repeat Antenatal Corticosteroids: A Randomized Controlled Trial
Mid-Childhood Outcomes of Repeat Antenatal Corticosteroids: A Randomized Controlled Trial
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DOI：
10.1542/peds.2016-0947
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发表时间：
2016-10-01
期刊：
影响因子：
8
通讯作者：
Doyle, Lex W.
中科院分区：
文献类型：
--
作者：
Crowther, Caroline A.;Anderson, Peter J.;Doyle, Lex W.
目的：评估重复剂量的产前糖皮质激素(S)是否对校正后的6~8岁儿童中期的神经发育和一般健康有有益影响。方法：将有极早产风险的妇女随机分为倍他米松(11.4mgCelstone Chronodose)或生理盐水安慰剂，如果极早产风险保持不变，每周重复一次。儿童期中期评估包括神经认知功能、行为、生长、肺功能、血压、与健康相关的生活质量和健康服务利用。结果：在1059名符合条件的长期幸存者中，963名(91%)包括在主要结果中，479名(91%)在重复使用皮质类固醇组，484名(91%)在安慰剂组。两组无神经感觉障碍的存活率相似(78.3%重复与77.3%安慰剂；风险比1.00，95%可信区间0.94-1.08)。两组的神经发育，包括认知功能、行为、体型、血压、呼吸测定和健康相关的生活质量相似，使用医疗服务的情况也相似。结论：产前重复剂量(S)皮质类固醇治疗在儿童期中期既没有益处，也没有坏处。考虑到相关的新生儿益处，我们的长期安全性的发现支持产前重复剂量(S)皮质类固醇的使用。对于怀孕32周前有早产风险的妇女，在产前皮质类固醇初始疗程后7天，临床医生可以考虑单次注射倍他米松，如果风险仍然存在，每周重复注射一次。
OBJECTIVE: To assess if exposure to repeat dose(s) of antenatal corticosteroids has beneficial effects on neurodevelopment and general health in mid-childhood, at 6 to 8 years' corrected age.METHODS: Women at risk for very preterm birth, who had received a course of corticosteroids >= 7 days previously, were randomized to intramuscular betamethasone (11.4 mg Celestone Chronodose) or saline placebo, repeated weekly if risk of very preterm birth remained. Mid-childhood assessments included neurocognitive function, behavior, growth, lung function, blood pressure, health-related quality of life, and health service utilization. The primary outcome was survival free of neurosensory disability.RESULTS: Of the 1059 eligible long-term survivors, 963 (91%) were included in the primary outcome; 479 (91%) in the repeat corticosteroid group and 484 (91%) in the placebo group. The rate of survival free of neurosensory disability was similar in both groups (78.3% repeat versus 77.3% placebo; risk ratio 1.00, 95% confidence interval, 0.94-1.08). Neurodevelopment, including cognitive function, and behavior, body size, blood pressure, spirometry, and health-related quality of life were similar in both groups, as was the use of health services.CONCLUSIONS: Treatment with repeat dose(s) of antenatal corticosteroids was associated with neither benefit nor harm in mid-childhood. Our finding of long-term safety supports the use of repeat dose(s) of antenatal corticosteroids, in view of the related neonatal benefits. For women at risk for preterm birth before 32 weeks' gestation, >= 7 days after an initial course of antenatal corticosteroids, clinicians could consider using a single injection of betamethasone, repeated weekly if risk remains.