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.