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 (SpO(2)/FiO(2)) 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. Country of recruitment: China. URL of trial registry record: https://www.chictr.org.cn/showproj.html?proj=254631 .