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经鼻持续气道正压通气与肺表面活性物质治疗早产儿呼吸窘迫综合征的随机对照研究

Less Invasive Surfactant Administration (LISA) vs. Intubation Surfactant Extubation (InSurE) in Preterm Infants with Respiratory Distress Syndrome: A Pilot Randomized Controlled Trial.

机构信息

Department of Neonatology, Bharati Vidyapeeth University Medical College, Pune, Maharashtra 411043, India.

Department of Pediatrics, Janaki Medical College and Teaching Hospital Pvt. Ltd, Janakpur 45600, Nepal.

出版信息

J Trop Pediatr. 2021 Aug 27;67(4). doi: 10.1093/tropej/fmab086.

Abstract

OBJECTIVE

There has been an endeavor in recent years, to administer surfactant by minimally invasive techniques to neonates with surfactant deficiency. The objective of this study was to compare the need for intubation and mechanical ventilation after surfactant delivery, using Less Invasive Surfactant Administration (LISA) technique and Intubation SURfactant Extubation (InSurE), in preterm infants with respiratory distress syndrome (RDS).

METHODS

We conducted a pilot randomized control trial (RCT) at a tertiary care center over a period of 18 months. Preterm neonates with RDS (gestational age 28-36 weeks) were randomized to receive surfactant within 6 h of birth by InSurE or LISA. The primary outcome was need for intubation and mechanical ventilation within 72 h of birth. Infants were followed until discharge for adverse events and complications.

RESULTS

A total of 40 infants were analyzed (20 in each group). There was no difference in the need for intubation and mechanical ventilation within 72 h of birth between the two groups [InSurE, 6 (30%) and LISA, 6 (30%), relative risk 1.0, 95% confidence interval 0.51-1.97]. About 15% of infants in both groups had adverse events during the procedure. There was no statistically significant difference in the rates of major complications or duration of respiratory support, hospital stay and mortality.

CONCLUSION

We found LISA to be feasible and equally effective as InSurE for surfactant administration in the treatment of RDS in preterm infants. Future larger RCTs are required to compare the efficacy and long-term outcomes of LISA with the standard invasive methods of surfactant administration.

摘要

目的

近年来,人们一直致力于通过微创技术向缺乏表面活性剂的新生儿施用表面活性剂。本研究的目的是比较经鼻持续气道正压通气(NCPAP)治疗失败的新生儿使用经鼻间歇正压通气(NIPPV)与常频机械通气(CMV)的临床转归。

方法

我们在一家三级护理中心进行了一项为期 18 个月的试点随机对照试验(RCT)。胎龄 28-36 周的有呼吸窘迫综合征(RDS)的早产儿,随机接受 InSurE 或 LISA 治疗。主要结局是出生后 72 小时内需要插管和机械通气。对婴儿进行随访,直到出院,以了解不良事件和并发症。

结果

共分析了 40 名婴儿(每组 20 名)。两组出生后 72 小时内需要插管和机械通气的情况无差异[InSurE,6(30%)和 LISA,6(30%),相对风险 1.0,95%置信区间 0.51-1.97]。两组约 15%的婴儿在操作过程中出现不良事件。主要并发症发生率、呼吸支持时间、住院时间和死亡率无统计学差异。

结论

我们发现 LISA 对于治疗早产儿 RDS 是可行的,与 InSurE 一样有效。需要未来更大规模的 RCT 来比较 LISA 与标准有创性表面活性剂给药方法的疗效和长期结果。

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