Trial reportFrontiers in pediatrics2026
A novel double-lumen tracheal tube-assisted InSurE versus LISA in preterm infants with RDS: a multicenter randomized trial.
Trial report in Frontiers in pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
9 authors.
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No grant is acknowledged in the PubMed record.
Abstract
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 ( 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 ( 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.
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