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经鼻持续气道正压通气治疗的 28 至 34 周呼吸窘迫综合征早产儿应用微创肺表面活性物质治疗与 InSurE 的随机对照研究。

Minimally invasive surfactant therapy versus InSurE in preterm neonates of 28 to 34 weeks with respiratory distress syndrome on non-invasive positive pressure ventilation-a randomized controlled trial.

机构信息

Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India.

出版信息

Eur J Pediatr. 2020 Aug;179(8):1287-1293. doi: 10.1007/s00431-020-03682-9. Epub 2020 May 27.

Abstract

Preterm neonates with respiratory distress syndrome (RDS) are commonly treated with surfactant by intubate surfactant extubate (InSurE) technique. Mode of surfactant administration has evolved towards less invasive technique in the last few years. We randomised 58 preterm infants of 28-34 weeks of gestation with RDS within 6 h of birth to receive surfactant by InSurE or minimally invasive surfactant therapy (MIST). Non-invasive positive pressure ventilation (NIPPV) was used as primary respiratory support. The main objective was to compare the need of invasive mechanical ventilation (IMV) in first 72 h of life and secondarily hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular haemorrhage (IVH) (> grade 2), bronchopulmonary dysplasia (BPD) and composite outcome of BPD/mortality. We did not find any difference in need of IMV in first 72 h between MIST and InSurE (relative risk with MIST, 0.62; 95% confidence interval, 0.22 to 1.32). No difference was observed in terms of hs PDA, IVH (> grade 2), BPD and composite outcome of BPD/mortality.Conclusion: There is no difference between MIST and InSurE in preterm neonates with RDS with NIPPV as a primary mode of respiratory support. Larger multicentre studies are needed to further explore differences in treatment failure and other secondary outcomes.Trial registration: www.ctri.nic.in id CTRI/2019/03/017992, registration date March 8, 2019. What is Known • InSurE is commonly used for many years for treatment of RDS in preterm neonates. • MIST has been introduced as a newer tool. What is New • MIST with feeding tube is comparable with InSurE in preterm infants with RDS in developing countries. •NIPPV can be used as primary respiratory support for MIST.

摘要

患有呼吸窘迫综合征(RDS)的早产儿通常采用气管内注入肺表面活性剂-拔管(InSurE)技术进行治疗。在过去的几年中,肺表面活性剂的给药方式已经向微创技术发展。我们将 58 例胎龄 28-34 周、出生后 6 小时内患有 RDS 的早产儿随机分为两组,一组接受 InSurE 治疗,另一组接受微创肺表面活性剂治疗(MIST)。非侵入性正压通气(NIPPV)作为主要的呼吸支持手段。主要目标是比较两组早产儿在出生后 72 小时内需要有创机械通气(IMV)的情况,次要目标是比较两组早产儿出现动脉导管未闭(hsPDA)、脑室内出血(IVH)(> 2 级)、支气管肺发育不良(BPD)和 BPD/死亡率的复合结局的差异。我们发现 MIST 组和 InSurE 组在出生后 72 小时内需要 IMV 的情况没有差异(MIST 组的相对风险为 0.62;95%置信区间,0.22 至 1.32)。两组在 hsPDA、IVH(> 2 级)、BPD 和 BPD/死亡率的复合结局方面也没有差异。结论:在使用 NIPPV 作为主要呼吸支持手段的情况下,MIST 和 InSurE 治疗 RDS 早产儿的效果没有差异。需要更大规模的多中心研究来进一步探索治疗失败和其他次要结局的差异。试验注册:www.ctri.nic.in id CTRI/2019/03/017992,注册日期 2019 年 3 月 8 日。已知:InSurE 是多年来治疗早产儿 RDS 的常用方法。MIST 作为一种新的工具已经推出。新内容:在发展中国家,对于患有 RDS 的早产儿,MIST 联合喂养管的方法与 InSurE 相当。NIPPV 可以作为 MIST 的主要呼吸支持手段。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e678/7251045/7f0ca8271092/431_2020_3682_Fig1_HTML.jpg

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