有创和微创表面活性剂给药方法的多中心随机试验显示，5至9岁时的肺功能测定结果相似。

Multi-centre randomised trial of invasive and less invasive surfactant delivery methods showed similar spirometry results at 5-9 years of age.

作者信息

Göpel Wolfgang, Kribs Angela, Roll Claudia, Wieg Christian, Teig Norbert, Hoehn Thomas, Welzing Lars, Vochem Matthias, Hoppenz Marc, Bührer Christoph, Mehler Katrin, Hubert Mechthild, Eichhorn Joachim, Schmidtke Susanne, Rausch Tanja Katrin, König Inke Regina, Härtel Christoph, Roth Bernd, Herting Egbert

机构信息

Department of Paediatrics, University Hospital of Schleswig-Holstein, University of Lübeck, Lübeck, Germany.

Department of Paediatrics, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany.

出版信息

Acta Paediatr. 2022 Nov;111(11):2108-2114. doi: 10.1111/apa.16499. Epub 2022 Aug 9.

DOI:10.1111/apa.16499

PMID:35896864

Abstract

AIM

We explored whether subnormal forced expiratory volume within 1 s (FEV ) at 5-9 years of age was lower in children born preterm who received less invasive surfactant administration (LISA) rather than surfactant via an endotracheal tube.

METHODS

The multi-centre, randomised Nonintubated Surfactant Application trial enrolled 211 preterm infants born at 23-26 weeks of gestation from 13 level III neonatal intensive care units from April 2009 to March 2012. They received surfactant via LISA (n = 107) or after conventional endotracheal intubation (n = 104). The follow-up assessments were carried out by a single team blinded to the group assignments. The main outcome was FEV < 80% of predicted values.

RESULTS

Spirometry was successful in 102/121 children. The other children died or were lost to follow-up. Median FEV was 93% (interquartile range 80%-113%) of predicted values in the LISA group and 86% (interquartile range 77-102%) in the control group (p = 0.685). Rates of FEV < 80% were 11/57 (19%) and 15/45 (33%), respectively, which was an absolute risk reduction of 14% (95% confidence interval -3.1% to 31.2%, p = 0.235). There were no differences in other outcome measures.

CONCLUSION

The proportion of children aged 5-9 years with subnormal FEV was not significantly different between the groups.

摘要

目的

我们探讨了5至9岁时1秒用力呼气量（FEV₁）低于正常的情况在接受微创表面活性剂给药（LISA）而非通过气管内导管给予表面活性剂的早产儿童中是否更低。

方法

多中心随机非插管表面活性剂应用试验纳入了2009年4月至2012年3月期间来自13个三级新生儿重症监护病房的211名孕23至26周出生的早产婴儿。他们通过LISA（n = 107）或在传统气管插管后（n = 104）接受表面活性剂。随访评估由对分组情况不知情的单一团队进行。主要结局是FEV₁<预测值的80%。

结果

121名儿童中102名成功进行了肺功能测定。其他儿童死亡或失访。LISA组FEV₁的中位数为预测值的93%（四分位间距80% - 113%），对照组为86%（四分位间距77 - 102%）（p = 0.685）。FEV₁<80%的发生率分别为11/57（19%）和15/45（33%），绝对风险降低为14%（95%置信区间 - 3.1%至31.2%，p = 0.235）。其他结局指标无差异。