A novel double-lumen tracheal tube-assisted InSurE versus LISA in preterm infants with RDS: a multicenter randomized trial.

BACKGROUND: Neonatal respiratory distress syndrome (NRDS) is a leading cause of mortality and long-term morbidity in preterm infants; however, safe and effective surfactant delivery to the neonatal lung remains challenging. We developed a novel dual-lumen tracheal tube (NDT) enabling surfactant administration without interrupting ventilation. This study aimed to evaluate the non-inferiority of the novel NDT-based technique compared with the Less Invasive Surfactant Administration (LISA) technique in reducing the need for early invasive mechanical ventilation. METHODS: The NDT, designed for a modified Intubation-Surfactant-Extubation (InSurE) technique (NDT-InSurE), features an embedded 0.2 mm channel. A multicenter, randomized controlled trial was conducted across six tertiary neonatal intensive care units (NICUs) in China. Preterm infants ≤ 32 weeks' gestation with NRDS were randomly assigned to the NDT-InSurE group (n = 69) or the LISA group (n = 69). The primary outcome was the requirement for mechanical ventilation within 72 h of treatment initiation due to non-invasive ventilation failure. Secondary outcomes included key clinical outcomes and major complications associated with NRDS. RESULTS: Baseline characteristics were comparable between the two groups. The primary outcome occurred in 10 infants (14.5%) in the NDT-InSurE group and 13 (18.8%) in the LISA group (P = 0.493; 95% CI, -12.5% to 4.0%). The upper bound of the 95% confidence interval was below the prespecified non-inferiority margin of 20%, indicating that the NDT-InSurE technique met the prespecified criterion for non-inferiority. Secondary outcomes, including total procedure duration, intubation time, duration of invasive ventilation, non-invasive ventilation, oxygen therapy, and total hospitalization time, showed no significant differences between the two groups (all P > 0.05). However, post-intubation arterial pH was lower in the NDT-InSurE group than in the LISA group (7.27 [7.25-7.35] vs. 7.38 [7.32-7.42], P = 0.004). Moreover, the incidence of major complications, including bronchopulmonary dysplasia, intraventricular hemorrhage, retinopathy of prematurity, and necrotizing enterocolitis, did not differ significantly between groups. CONCLUSIONS: NDT-InSurE may serve as a practical alternative to LISA, particularly in settings where LISA expertise or resources are limited. Further large-scale, multicenter studies with long-term follow-up are warranted to confirm these findings and further evaluate the efficacy and safety of this technique. CLINICAL TRIAL REGISTRATION: This study was registered at the China Clinical Trial Registry (https://www.chictr.org.cn/), Registration Number: ChiCTR2300076354.The registration date is October 7th, 2023.