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)

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.