A randomized controlled equivalence trial of pulmonary surfactant administration via laryngeal mask airway versus endotracheal intubation

Sep 30, 2026

Uploaded by Mimi

Neonatal respiratory distress syndrome (NRDS) is driven by pulmonary surfactant (PS) deficiency and leads to progressive respiratory failure within hours of birth. Exogenous PS replacement using the INSURE technique has reduced mortality and improved outcomes, but the laryngeal mask airway (LMA) may provide a noninvasive alternative. This randomized controlled equivalence trial compares clinical efficacy and safety between PS delivery via LMA versus endotracheal intubation, assessing oxygenation, airway placement, adverse events, PS residue, repeat dosing, and pneumothorax incidence.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages11

Reading Time28 min

AccessFree to download

Abstract

Methods

Discussion

Trial registration

Registry name and identifying information

Registration date and study PID

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Administrative information

Wang et al. Trials (2026) 27:11 [https://doi.org/10.1186/s13063-025-09310-x](https://doi.org/10.1186/s13063-025-09310-x) Trials STUDY PROTOCOL Open Access A randomized controlled equivalence trial of pulmonary surfactant administration via laryngeal mask airway versus endotrachealintubation Aoyu Wang1, Chao Chen1, Yi Huang1, Wenli Liu1, Ke Tian1, Rong Zhou1, Zhu Yuan1, Jun Zhu1, Yong Hu 1, Haiting Liu1, Surong Duan3 and Hua Wang1,2* Abstract Background Neonatal respiratory distress syndrome (NRDS) is a life-threatening condition marked by progressive respiratory failure due to pulmonary surfactant (PS) deficiency, typically presenting within hours of birth. Exogenous pulmonary surfactant replacement therapy has significantly reduced mortality associated with NRDS and improved clinical outcomes. The current standard of care involves the intubation-surfactant-extubation (INSURE) technique. However, emerging evidence suggests that the laryngeal mask airway (LMA) may serve as a viable noninvasive alternative for neonatal resuscitation and therapeutic administration. This randomized controlled equivalence trial aims to compare the clinical efficacy and safety profiles of LMA and INSURE in delivering PS for NRDS management. Methods Some of the preterm infants diagnosed with NRDS and requiring the first treatment with PS were included in this study. The included subjects were randomly assigned to the LMA group (experimental group) and the INSURE group (control group) by means of envelopes, and were given PS treatment by LMA or INSURE, respectively, and the SF index (SpO2/FiO2) before and after the use of PS; the placement time of artificial airway, the episodes of hypoxemia, bradycardia and tachycardia during artificial airway placement; the amount of PS residue in the stomach after the use of PS; the incidence of the second use of PS, and the incidence of pneumothorax were also monitored in order to compare the effect and prognosis of the two methods of treating NRDS. Discussion The use of PS with INSURE is currently the most prominent and classic method. Although some recent studies suggest that non-invasive use of PS through a laryngeal mask is also effective, relevant research remains limited. Through this trial, we aim to gather more data regarding the use of PS with a laryngeal mask and further validate its effectiveness. Trial registration Name of the registry: A randomized controlled trial of pulmonary surfactant administration via laryngeal mask airway versus endotracheal intubation. Trial identifying number: ChiCTR2500096315 . Date of registration in primary registry: 2025-01-21 00:00:00 . PID: 254631. *Correspondence: Hua Wang [wanghua@scu.edu.cn](wanghua@scu.edu.cn) Full list of author information is available at the end of the article © The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit [http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/.)[.](http://creativecommons.org/licenses/by/4.0/.) Wang et al. Trials (2026) 27:11 Page 2 of 11 Country of recruitment: China. URL of trial registry record: [https://www.chictr.org.cn/showproj.html?proj=254631](https://www.chictr.org.cn/showproj.html?p

FAQs

What is the goal of this randomized controlled equivalence trial?

To compare the clinical efficacy and safety of delivering pulmonary surfactant (PS) via a laryngeal mask airway (LMA) versus delivering PS using the INSURE approach (endotracheal intubation).

How are study groups assigned and what interventions are compared?

Preterm infants requiring first PS treatment are randomly assigned to the LMA group or the INSURE group, and receive PS via LMA or via endotracheal intubation, respectively.

Which outcomes are monitored to evaluate efficacy and prognosis?

Outcomes include SF index (SpO2/FiO2) before and after PS, placement time of the airway, episodes of hypoxemia, bradycardia and tachycardia during placement, PS residue in the stomach, second PS use incidence, and pneumothorax incidence.

Sep 30, 2026

Uploaded by Mimi