Newborn Research, Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland.
Syst Rev. 2021 Jan 6;10(1):9. doi: 10.1186/s13643-020-01573-6.
Respiratory distress syndrome (RDS) is the most common cause of respiratory failure in preterm infants. Treatment consists of respiratory support and exogenous surfactant administration. Commonly, surfactant is administered intratracheally. However, this requires airway instrumentation and subsequent fluid instillation which may be harmful. Surfactant nebulization (SN) may offer a safe and effective alternative for surfactant administration, but the clinical efficacy is not yet established. Thus, this systematic review and meta-analysis of randomized controlled trials will summarize the available evidence to determine the effectiveness and safety of SN for the prevention of intubation and subsequent mechanical ventilation at 72 h after birth.
A systematic literature search in Medline, Embase, and The Cochrane Library will be performed, and all randomized controlled trials (RCTs) and quasi-RCTs from published articles, presentations, and trial registries will be included in this meta-analysis. Titles and abstracts of all records identified in the search will be screened by two reviewers independently. Data on preterm infants (≤ 37 weeks) receiving nebulized surfactant in the first 72 h after birth for the treatment or prevention of RDS will be evaluated. Primary outcome is the intubation rate by 72 h after birth, and secondary outcomes include peridosing safety effects as well as major neonatal morbidities. Risk of bias will be assessed using the revised Cochrane ROB tool, and subgroup analyses will be performed to evaluate potential confounding factors. Publication bias will be assessed by examining a funnel plot. The meta-analysis will be performed using a fixed-effects model.
This review will provide an evidence-based tool for information about surfactant nebulization, illustrating the current knowledge and hopefully revealing potential novel avenues for researchers and clinicians alike.
This review is registered with the publicly available resource PROSPERO ( CRD42020175625 ).
呼吸窘迫综合征（RDS）是早产儿呼吸衰竭最常见的原因。治疗包括呼吸支持和外源性表面活性剂的应用。通常，表面活性剂经气管内给药。然而，这需要气道仪器操作和随后的液体灌输，这可能是有害的。表面活性剂雾化（SN）可能为表面活性剂的给药提供一种安全有效的替代方法，但临床疗效尚未确定。因此，本系统评价和随机对照试验的荟萃分析将总结现有证据，以确定 SN 预防出生后 72 小时内插管和随后机械通气的有效性和安全性。
将在 Medline、Embase 和 The Cochrane Library 中进行系统文献检索，并将来自已发表文章、演示文稿和试验登记处的所有随机对照试验（RCT）和准 RCT 纳入本荟萃分析。由两名评审员独立筛选检索到的所有记录的标题和摘要。将评估在出生后 72 小时内接受雾化表面活性剂治疗或预防 RDS 的早产儿（≤37 周）的数据。主要结局是出生后 72 小时内的插管率，次要结局包括剂量安全性效应以及主要新生儿并发症。使用修订后的 Cochrane ROB 工具评估偏倚风险，并进行亚组分析以评估潜在的混杂因素。通过检查漏斗图评估发表偏倚。荟萃分析将使用固定效应模型进行。
本综述将为表面活性剂雾化提供循证工具，说明当前的知识，希望为研究人员和临床医生揭示潜在的新途径。
本综述在公开可用的资源 PROSPERO（CRD42020175625）中进行了注册。
