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Objective <p>Deficiency of pulmonary surfactant (PS) induces the onset of neonatal respiratory distress syndrome (RDS), 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 RDS are limited.</p> Methods <p>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&#xa0;weeks of gestation and weighing less than 1500&#xa0;g who presented after birth with RDS with the need for noninvasive ventilatory support as initial treatment were eligible for inclusion.</p> Results <p>Of the 49 eligible premature infants, 25 were randomized to the VMN group, and 24 to the less invasive surfactant administration (LISA) group. We did not find a difference in the need for mechanical ventilation via an endotracheal tube (MVET) within 72&#xa0;h between the VMN and LISA groups (3 [12.00%] vs. 5 [20.80%]; odds ratio, 0.52; 95% confidence intervals (CI), 0.11–2.46; <i>P</i> = 0.653). Comparing the LISA group, the incidence of apnea of prematurity and transient decrease in oxygen saturation was lower in the VMN group (2[8.00%] vs. 10 [41.67%]; odds ratio [OR], 0.10; 95% CI 0.02–0.54, <i>P</i> = 0.003; 3[12.00%] vs. 16[66.67%]; OR, 0.10; 95% CI 0.02–0.30, <i>P</i> &lt; 0.001). However, there was no difference in the bronchopulmonary dysplasia (BPD), death in hospital, pneumothorax, periventricular leukomalacia (PVL), retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), periventricular–intraventricular hemorrhage (PIVH), and application of PS again between the two groups (all <i>P</i> &gt; 0.05).</p> Conclusion <p>In this exploratory clinical trial, compared with LISA, the noninvasive VMN technique may be a safe and well-tolerated approach for PS delivery in preterm infants with RDS.</p> <p><i>Trial registration</i>: ChiCTR2300072262 (<a href="https://www.chictr.org.cn">https://www.chictr.org.cn</a>).“</p>

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Vibrating mesh nebulizers vs. less invasive surfactant administration in the treatment of preterm respiratory distress syndrome: a multicenter, open-label, exploratory, randomized clinical trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月31日

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  • Yiyao Jiang,
  • Xin Chen,
  • Runa Li,
  • Hui Wang,
  • Hanqing Wang,
  • Qian Guo,
  • Jinhong Li,
  • Dexin Li,
  • Bo Wang,
  • Hong Xu,
  • Qiaoqiao Zou,
  • Hong Wan,
  • Rui Rao

摘要

Objective

Deficiency of pulmonary surfactant (PS) induces the onset of neonatal respiratory distress syndrome (RDS), 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 RDS are limited.

Methods

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.

Results

Of the 49 eligible premature infants, 25 were randomized to the VMN group, and 24 to the less invasive surfactant administration (LISA) group. We did not find a difference in the need for mechanical ventilation via an endotracheal tube (MVET) within 72 h between the VMN and LISA groups (3 [12.00%] vs. 5 [20.80%]; odds ratio, 0.52; 95% confidence intervals (CI), 0.11–2.46; P = 0.653). Comparing the LISA group, the incidence of apnea of prematurity and transient decrease in oxygen saturation was lower in the VMN group (2[8.00%] vs. 10 [41.67%]; odds ratio [OR], 0.10; 95% CI 0.02–0.54, P = 0.003; 3[12.00%] vs. 16[66.67%]; OR, 0.10; 95% CI 0.02–0.30, P < 0.001). However, there was no difference in the bronchopulmonary dysplasia (BPD), death in hospital, pneumothorax, periventricular leukomalacia (PVL), retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), periventricular–intraventricular hemorrhage (PIVH), and application of PS again between the two groups (all P > 0.05).

Conclusion

In this exploratory clinical trial, compared with LISA, the noninvasive VMN technique may be a safe and well-tolerated approach for PS delivery in preterm infants with RDS.

Trial registration: ChiCTR2300072262 (https://www.chictr.org.cn).“