Vibrating Mesh Nebulizers vs. Less Invasive Surfactant Administration in the Treatment of Preterm Respiratory Distress Syndrome: A Multicenter, Open-label, Randomized Clinical Trial

Deficiency of pulmonary surfactant (PS) induces the onset of neonatal respiratory distress syndrome, which can lead to progressively worsening respiratory failure and even death. However, studies on improving lung function via the use of vibrating mesh nebulizer (VMN) technology to deliver PS to premature infants with NRDS are limited. This prospective multicenter, open-label, exploratory, randomized clinical trial, including 2 parallel groups and a 1:1 allocation, was conducted in 7 hospitals from Jan. 1, 2023, to Dec. 31, 2024. Premature infants born at less than 32 weeks of gestation and weighing less than 1500 g who presented after birth with RDS with the need for noninvasive ventilatory support as initial treatment were eligible for inclusion. Of the 49 eligible premature infants, 25 infants were randomized to the VMN group, and 24 infants were randomized to the LISA group. The main objective was to investigate the need for mechanical ventilation via an endotracheal tube (MVET) within 72 hours and the incidence of apnoea of prematurity, arrhythmia, and transient decrease in oxygen saturation. We did not find difference in need of MVET within 72 hours between VMN and LISA group (3 [12%] vs. 5 [20.8%]; odds ratio, 0.52; 95% confidence intervals, 0.11-2.46; P= 0.653). Comparing the LISA group, the incidence of apnoea of prematurity, arrhythmia, and transient decrease in oxygen saturation was lower in VMN group (all P <0.05). Conclusion: In this clinical trial, the noninvasive technique of VMN is a feasible and safe method for delivering PS. However, there was no difference between VMN and LISA in the efficacy of neonate RDS. Further RCTs are needed to test whether VMN can replace LISA in the treatment of RDS. Trial registration: ChiCTR2300072262 (https://www.chictr.org.cn), registered on 08/06/2023.