Early low-dose hydrocortisone: is the neurodevelopment affected?
Early low-dose hydrocortisone: is the neurodevelopment affected?
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早期小剂量氢化可的松：神经发育是否受到影响？
DOI：
10.1038/s41372-018-0086-y
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发表时间：
2018
期刊：
影响因子：
--
通讯作者：
Farrow,KathrynN
中科院分区：
文献类型：
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作者：
Ofman,Gaston;Perez,Marta;Farrow,KathrynN
检查类型预后;一项干预性随机对照试验的探索性二次分析：在极早产儿（<28周）中，与安慰剂相比，早期低剂量氢化可的松是否与2岁时的神经发育障碍相关？方法患者：2008年至2014年在法国进行的PREMINUS试验中入选的存活婴儿。干预：一项在妊娠24 0/7周至27 6/7周出生且出生后24小时内出生的婴儿中进行的双盲、多中心、随机、安慰剂对照试验，分配接受安慰剂或低剂量氢化可的松治疗（0.5 mg/kg每天两次，持续7天，随后0.5 mg/kg每天一次，持续3天）。（氢化可的松组为73%，安慰剂组为70%），有轻度神经发育障碍（氢化可的松组20%，安慰剂组18%），或伴有中度至重度神经发育障碍（氢化可的松组7%对安慰剂组11%），两组之间无统计学显著差异（p= 0.33）。使用标准化的神经系统检查的患者的定性评估也没有统计学显着差异组之间（p= 0.87）。研究conclusionIn这个后续研究的早产儿谁被随机分配在出生时接受低剂量氢化可的松或安慰剂为10天，氢化可的松治疗与任何不良影响的神经发育结果在22个月的校正年龄。
Type of investigationPrognosis; exploratory secondary analysis of an interventional randomized controlled trial.QuestionIn extremely preterm infant (<28 weeks), is early low-dose hydrocortisone compared to placebo associated with neurodevelopmental impairment at 2 years of age?MethodsPatients: Surviving infants enrolled in the PREMILOC trial conducted in France between 2008 and 2014.Intervention: Double-blind, multicenter, randomized, placebo-controlled trial of infants born between 24 0/7 weeks and 27 6/7 weeks of gestation and before 24 h of postnatal age, assigned to receive either placebo or low-dose hydrocortisone (0.5 mg/kg twice per day for 7 days, followed by 0.5 mg/kg per day for 3 days).Main resultsFor the pre-specified exploratory outcome, the distribution of patients without neurodevelopmental impairment (73% in the hydrocortisone group vs. 70% in the placebo group), with mild neurodevelopmental impairment (20% in the hydrocortisone group vs. 18% in the placebo group), or with moderate to severe neurodevelopmental impairment (7% in the hydrocortisone group vs. 11% in the placebo group) was not found to be statistically significantly different between the two groups (p= 0.33). Qualitative assessment of patients using standardized neurological examination also was not statistically significantly different between groups (p= 0.87).Study conclusionIn this follow-up study of premature infants who were randomly assigned at birth to receive low-dose hydrocortisone or placebo for 10 days, hydrocortisone treatment was not associated with any adverse effects on neurodevelopmental outcome at 22 months of corrected age.