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)

Overview

Journal BMJ Open

Specialty General Medicine

Date 2024 Dec 9

PMID 39653560

Authors

Jin Gao

Hanmei Xiong

Panrong Nie

Hong Yang

Dan Li

Xingmei Deng

Yuan Shi

Chuanfeng Li

Weihong Yu

Jie Yang

Yuxuan Du

Affiliations

Soon will be listed here.

Abstract

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.

References

Schmidt A, Ramamoorthy C . Bronchopulmonary dysplasia. Paediatr Anaesth. 2021; 32(2):174-180. DOI: 10.1111/pan.14365. View

Roberts C, Halibullah I, Bhatia R, Green E, Kamlin C, Davis P . Outcomes after Introduction of Minimally Invasive Surfactant Therapy in Two Australian Tertiary Neonatal Units. J Pediatr. 2020; 229:141-146. DOI: 10.1016/j.jpeds.2020.10.025. View

Papile L, BURSTEIN J, Burstein R, KOFFLER H . Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 1978; 92(4):529-34. DOI: 10.1016/s0022-3476(78)80282-0. View

Chiang M, Quinn G, Fielder A, Ostmo S, Paul Chan R, Berrocal A . International Classification of Retinopathy of Prematurity, Third Edition. Ophthalmology. 2021; 128(10):e51-e68. PMC: 10979521. DOI: 10.1016/j.ophtha.2021.05.031. View

Jena S, Bains H, Pandita A, Verma A, Gupta V, Kallem V . Surfactant therapy in premature babies: SurE or InSurE. Pediatr Pulmonol. 2019; 54(11):1747-1752. DOI: 10.1002/ppul.24479. View

Mohammadizadeh M, Ghehsareh Ardestani A, Sadeghnia A . Early administration of surfactant via a thin intratracheal catheter in preterm infants with respiratory distress syndrome: Feasibility and outcome. J Res Pharm Pract. 2015; 4(1):31-6. PMC: 4326969. DOI: 10.4103/2279-042X.150053. View

Zhu J, Bao Y, Du L, Huang H, Lv Q, Jiang Y . Less invasive surfactant administration versus endotracheal surfactant instillation followed by limited peak pressure ventilation in preterm infants with respiratory distress syndrome in China: study protocol for a randomized controlled trial. Trials. 2020; 21(1):516. PMC: 7289227. DOI: 10.1186/s13063-020-04390-3. View

Patel R, Ferguson J, McElroy S, Khashu M, Caplan M . Defining necrotizing enterocolitis: current difficulties and future opportunities. Pediatr Res. 2020; 88(Suppl 1):10-15. PMC: 8096612. DOI: 10.1038/s41390-020-1074-4. View

Meyer S, Franz A, Bay J, Gortner L . Developing a better and practical definition of bronchopulmonary dysplasia. Acta Paediatr. 2017; 106(5):842. DOI: 10.1111/apa.13783. View

10.

Li C, Du Y, Yang K, Cao H, Yang H, Zhang C . Safety and efficacy of a novel double-lumen tracheal tube in neonates with RDS: A prospective cohort study. Front Pediatr. 2022; 10:1032044. PMC: 9760922. DOI: 10.3389/fped.2022.1032044. View

11.

Yang G, Hei M, Xue Z, Zhao Y, Zhang X, Wang C . Effects of less invasive surfactant administration (LISA) via a gastric tube on the treatment of respiratory distress syndrome in premature infants aged 32 to 36 weeks. Medicine (Baltimore). 2020; 99(9):e19216. PMC: 7478768. DOI: 10.1097/MD.0000000000019216. View

12.

Barkhuff W, Soll R . Novel Surfactant Administration Techniques: Will They Change Outcome?. Neonatology. 2019; 115(4):411-422. DOI: 10.1159/000497328. View

13.

Bell M, TERNBERG J, Feigin R, Keating J, Marshall R, Barton L . Neonatal necrotizing enterocolitis. Therapeutic decisions based upon clinical staging. Ann Surg. 1978; 187(1):1-7. PMC: 1396409. DOI: 10.1097/00000658-197801000-00001. View

14.

Buyuktiryaki M, Alarcon-Martinez T, Simsek G, Canpolat F, Tayman C, Oguz S . Five-year single center experience on surfactant treatment in preterm infants with respiratory distress syndrome: LISA vs INSURE. Early Hum Dev. 2019; 135:32-36. DOI: 10.1016/j.earlhumdev.2019.06.004. View

15.

Tana M, Tirone C, Aurilia C, Lio A, Paladini A, Fattore S . Respiratory Management of the Preterm Infant: Supporting Evidence-Based Practice at the Bedside. Children (Basel). 2023; 10(3). PMC: 10047523. DOI: 10.3390/children10030535. View

16.

Kaniewska U, Gulczynska E . The influence of the technique of surfactant administration (LISA vs INSURE) on the outcomes of respiratory distress syndrome treatment in preterm infants. Dev Period Med. 2019; 23(3):163-171. PMC: 8522404. View

17.

Kempley S, Moreiras J, Petrone F . Endotracheal tube length for neonatal intubation. Resuscitation. 2008; 77(3):369-73. DOI: 10.1016/j.resuscitation.2008.02.002. View

18.

Chen L, Wang L, Ma J, Feng Z, Li J, Shi Y . Nasal High-Frequency Oscillatory Ventilation in Preterm Infants With Respiratory Distress Syndrome and ARDS After Extubation: A Randomized Controlled Trial. Chest. 2019; 155(4):740-748. DOI: 10.1016/j.chest.2019.01.014. View

19.

Klotz D, Porcaro U, Fleck T, Fuchs H . European perspective on less invasive surfactant administration-a survey. Eur J Pediatr. 2016; 176(2):147-154. DOI: 10.1007/s00431-016-2812-9. View

20.

Abdel-Latif M, Davis P, Wheeler K, De Paoli A, Dargaville P . Surfactant therapy via thin catheter in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2021; 5:CD011672. PMC: 8109227. DOI: 10.1002/14651858.CD011672.pub2. View