Application of a new type of double-lumen endotracheal tube in preterm infants with respiratory distress syndrome: study protocol for a non-inferiority randomised controlled trial (NISA)
Authors: Gao Jin , Xiong Hanmei , Nie Panrong , Yang Hong , Li Dan , Deng Xingmei , Shi Yuan , Li Chuanfeng , Yu Weihong , Yang Jie , Du Yuxuan 
Published: December 2024

Background

Non-invasive ventilation combined with pulmonary surfactant (PS) therapy is recognised as a method for treating neonatal respiratory distress syndrome (NRDS). Among the administration, methods of PS, INtubation–SURfactant–Extubation (InSurE) and less invasive surfactant administration (LISA) have been widely discussed.

LISA technique prevents patients from exposure to invasive positive pressure ventilation (PPV), thus improving the long-term outcomes of the respiratory system, but it faces challenges in resource-limited areas due to complexity and cost. The InSurE technique remains prevalent due to its simplicity. The new dual-lumen tracheal tube (NDT) is designed with a 0.2 mm diameter pathway on the sidewall for continuous administration of PS under continuous PPV. The purpose of this study is to compare the safety and effectiveness of the NDT InSurE technique versus the LISA technique in non-invasive ventilation for premature infants with NRDS, and to explore the applicability of the NDT.

Methods and analysis

This is a multicentre randomised controlled trial, planned to recruit 132 premature infants who meet the inclusion criteria from January 2024 to December 2024. They will be randomly assigned to the InSurE group using the NDT (experimental group) and the LISA group. The study will be conducted in six tertiary neonatal intensive care units in Yunnan province. The primary outcome is the rate of mechanical ventilation within 72 hours after birth. Secondary outcomes include the procedure data and major complications of NRDS, also include respiratory infections within 12 months of corrected age.

Discussion

We assume that the NDT is not worse than the LISA catheter. Based on the characteristics of the NDT, continuous PPV during drug administration, we designed this study to compare the InSurE technique using the NDT with the LISA technique. We aim to explore more benefits of the NDT and confirm wider clinical applicability. It will provide more options for doctors when using the InSurE technique.

Ethics and dissemination

This study complies with the Declaration of Helsinki and was approved by the medical ethics committee of Kunming Children’s Hospital (approval number 2023-03-297-K01) and theoretical committee of Qujing Maternal and Child Health Hospital. At the end of the study, we will organise the data, complete the statistical analysis and present our research findings in the form of a paper.

There is lack of comparative research on the NDT InSurE technique and LISA, making this study innovative. If the hypothesis is confirmed, clinicians will have an additional option when using PS, and it may even replace endotracheal tube in InSurE technique. The limited number of preterm infants planned for recruitment in the study may restrict stratified analyses based on gestational age, which could affect the broad applicability of the study results. The study is limited to preterm infants with a gestational age of less than 32 weeks, which means that the results may not be applicable to preterm infants with a larger gestational age or other patient populations.