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在一项横断面观察性多中心研究的临床环境中,与气管插管和机械通气相比,接受较少有创性肺表面活性剂治疗的极低出生体重儿的治疗和结局数据。

Treatment and outcome data of very low birth weight infants treated with less invasive surfactant administration in comparison to intubation and mechanical ventilation in the clinical setting of a cross-sectional observational multicenter study.

机构信息

Department of Neonatology, Children's Hospital of the University of Cologne, Kerpener Strasse 62, 50937, Cologne, Germany.

Department of Pediatrics, University of Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.

出版信息

Eur J Pediatr. 2018 Aug;177(8):1207-1217. doi: 10.1007/s00431-018-3179-x. Epub 2018 May 28.

Abstract

UNLABELLED

The aim of this study was to contribute further to existing randomized controlled trials and meta-analyses showing advantages in the outcome of less invasive surfactant administration (LISA)-treated infants and add new aspects concerning treatment and outcome data collected in the routine clinical setting. Four hundred seven very low birth weight infants who received surfactant via either LISA or intubation methods were enrolled in the observational cross-sectional multicenter study. To compare infants in terms of surfactant administration, we used an exact matching procedure (the same gestational age, severe perinatal depression (pH < 7.10), birth weight < 10th percentile, antenatal steroid treatment, and the same gender). To check for robustness, we performed repeated matching. LISA-treated infants required significantly less mechanical ventilation during hospital stay (p < 0.001) and days with supplemental oxygen (p = 0.03). Analgesics and sedatives were used less often during the stay (p < 0.001). Infants treated with LISA had significantly lower rates of bronchopulmonary dysplasia (p = 0.003). LISA failure infants were identified as more likely to be small for gestational age and more immature.

CONCLUSION

Our study complements former results with advantages for LISA-treated infants in mechanical ventilation and bronchopulmonary dysplasia in the clinical routine.

TRIAL REGISTRATION

DRKS00004589 What is Known: • According to existing literature, LISA-treated infants seem to have some favors in terms of treatment and outcome data. Observational studies in routine clinical setting are missing. What is New: • Data of 407 VLBW infants collected in routine clinical setting showed that LISA-treated infants needed less mechanical ventilation and fewer days with supplemental oxygen and less analgesics and sedatives. A reduced risk of BPD could be showed. SGA infants seem to have higher risks of LISA failure.

摘要

目的

本研究旨在进一步补充现有的随机对照试验和荟萃分析结果,这些结果表明,接受微创表面活性剂给药(LISA)治疗的婴儿在治疗结果方面具有优势,并增加有关常规临床环境中收集的治疗和结果数据的新内容。本观察性横断面多中心研究共纳入 407 例极低出生体重儿,他们接受了 LISA 或插管法给予的表面活性剂。为了比较两组婴儿的表面活性剂给药情况,我们使用了精确匹配程序(相同的胎龄、严重围产期酸中毒(pH<7.10)、出生体重<第 10 百分位、产前类固醇治疗和相同性别)。为了检查稳健性,我们进行了重复匹配。LISA 治疗组婴儿在住院期间需要的机械通气显著减少(p<0.001),需要补充氧气的天数也显著减少(p=0.03)。住院期间使用的镇痛药和镇静剂也较少(p<0.001)。LISA 治疗组婴儿的支气管肺发育不良(BPD)发生率显著降低(p=0.003)。LISA 治疗失败的婴儿被认为是更小的胎儿生长受限和更不成熟。

结论

本研究在常规临床实践中补充了 LISA 治疗婴儿在机械通气和支气管肺发育不良方面具有优势的结果。

试验注册

DRKS00004589 已知内容:• 根据现有文献,LISA 治疗的婴儿在治疗和结局数据方面似乎有一些优势。目前缺少常规临床环境中的观察性研究。新内容:• 在常规临床环境中收集的 407 例极低出生体重儿的数据表明,LISA 治疗的婴儿需要较少的机械通气,较少的补充氧气天数,以及较少的镇痛药和镇静剂。可以显示 BPD 的风险降低。SGA 婴儿似乎有更高的 LISA 治疗失败风险。

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