EBNEO COMMENTARY: SURFACTANT ADMINISTRATION VIA LARYNGEAL MASK AIRWAY VERSUS BRIEF TRACHEAL INTUBATION IN PRETERM INFANTS.

[EBNEO]

Mary Eileen Foster and Harsha Gowda from Neonatal Unit, Birmingham Heartlands Hospital, UK, write an EbNeo Review on: Gallup JA, Ndakor SM, Pezzano C, Pinheiro JMB. Randomized Trial of Surfactant Therapy via Laryngeal Mask Airway Versus Brief Tracheal Intubation in Neonates Born Preterm. J Pediatr. 2023 Mar;254:17-24.e2. doi: 10.1016/j.jpeds.2022.10.009. Epub 2022 Oct 12. PMID: 36241051

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Acta Commentary:

Acta Paediatrica - 2024 - Foster - EBNEO commentary Surfactant administration via laryngeal mask airway versus brief.pdf

 

Globally, neonatal practices are intensely focused on reducing the prevalence of bronchopulmonary dysplasia (BPD) and its associated comorbidities. The administration of surfactant has been shown to reduce the risk of death and BPD in preterm infants.

Since its introduction in 19801, surfactant administration has revolutionised the treatment of respiratory distress syndrome (RDS), consequently diminishing the risk of developing BPD4. Over the decades, the strategies for surfactant delivery have evolved significantly, encompassing a range of different techniques from INSURE method (Intubation-SURfactant-Extubation) to less invasive surfactant administration (LISA). INSURE was developed to reduce the amount of time neonates remained intubated and ventilated to reduce its complications while still receiving surfactant and reducing BPD, meanwhile LISA was developed after a neonates failed to come off the ventilator with the INSURE method7. However, the standard approach to administering surfactant still involves the use of laryngoscope either direct or video for endotracheal intubation with ETT or LISA catheter for surfactant administration.  These approaches may need pain relief or sedation.

In 2013, the laryngeal mask airway (LMA) has emerged as an effective method for surfactant delivery, showcasing a significantly reduces the need for intubation and mechanical ventilation in premature infants with moderate respiratory distress syndrome (RDS)2. The advantages of utilising LMA are significant, including the obviation of laryngoscope use, which simplifies the procedure for operators. This, in turn, reduces the necessity for sedative medications. Furthermore, LMA presents minimal contraindications, which primarily encompass maxillofacial, tracheal, or established pulmonary malformations. However, a notable limitation of LMA use is the absence of sizes appropriate for very low birth weight or extremely premature infants, with the smallest available size being 1, which is only licensed to be used in infants who are more than 2 kilograms6. Additionally, there is a noticeable gap in scientific validation for this approach.

In this current study, we can see that LMA had a lower failure rate (20%) compared to ETT (29%), demonstrating its non-inferiority when it came to this paper’s primary outcome. This paper shows that administering surfactant via LMA can have advantages over the more traditional methods. Some of these advantages include that it is more user friendly, and less training required for its use. Sedative medications, such as remifentanil, can themselves increase the failure rate in more traditional methods such as InSuRe.

These findings provide valuable insight into the ongoing discourse on minimally invasive surfactant administration, with a method that could potentially decrease the need for mechanical ventilation and its associated risks. However, the non-inferiority margin of 20% is notably generous, potentially obscuring clinically significant differences between the two methods. This choice, coupled with the small sample size, attenuates the study’s statistical power, rendering the conclusion of non-inferiority less compelling than it might otherwise be.

Furthermore, the methodological divergence in pre-medication between groups injects an additional variable into the comparative analysis this could have been attenuated if the comparison would have been done between LMA and another less invasive surfactant administration technique such as LISA. Another limitation is failure to reach the target sample size due to slow recruitment and Covid 19 pandemic. It is worth mentioning that there was also a mid-protocol change which can affect the way we interpret the results. The changes included difference in timings to define failure of procedure (ventilation in the first 72 hours rather than 120 hours), saturations target in eligibility criteria (90-95% vs 85%), changing randomization allocation from 1:1 to 2:1 favoring LMA, which can introduce contextual bias to units were LMA is not seen as favorable, and lastly that it was intended as a multi-centric trial.

While the study presents an intriguing alternative to traditional surfactant administration methods, its findings must be interpreted with caution. The pursuit of innovation in neonatal care is commendable, but it must be grounded in solid, evidence-based research to ensure that new practices offer tangible benefits without compromising patient safety. As such, this trial represents an important step in an ongoing journey rather than a definitive destination. Further large multi-centric RCT data is required before the results can be generalised and adopted for routine practice.

References: 

1) Halliday HL. History of surfactant from 1980. Biol Neonate. 2005;87(4):317-22. doi: 10.1159/000084879. Epub 2005 Jun 1. PMID: 15985754.

2) Pejovic, N. J., Myrnerts Höök, S., Byamugisha, J., Alfvén, T., Lubulwa, C., Cavallin, F., & Tylleskär, T. (2020). A Randomized Trial of Laryngeal Mask Airway in Neonatal Resuscitation. The New England Journal of Medicine, 383(22), 2138-2147. https://doi.org/10.1056/NEJMoa2005333

3) Glenn T, Fischer L, Markowski A, Carr CB, Malay S, Hibbs AM. Complicated Intubations are Associated with Bronchopulmonary Dysplasia in Very Low Birth Weight Infants. Am J Perinatol. 2023 Aug;40(11):1245-1252. doi: 10.1055/s-0041-1736130. Epub 2021 Sep 9. PMID: 34500482; PMCID: PMC9239052.

4) Hsiu-Lin Chen, Shu-Ting Yang, Pin-Chun Su, & Hao-Wei Chung. (2024). The outcomes of preterm infants with neonatal respiratory distress syndrome treated by minimally invasive surfactant therapy and non-invasive ventilation. Biomedicines, 12(4), 838. https://doi.org/10.3390/biomedicines12040838

5) Roberts, K. D., Brown, R., Lampland, A. L., Leone, T. A., Rudser, K. D., & Finer, N. N., et al. (2018). Laryngeal mask airway for surfactant administration in neonates: A randomized, controlled trial. Journal of Pediatrics, 193, 40-46. https://doi.org/10.1016/j.jpeds.2017.09.080

6) Aitken, J., & O’Shea, J. (2021). Could laryngeal mask airways be used to stabilise neonates at birth by those with limited intubation experience? *Archives of Disease in Childhood, 106*(2), 197-200. https://doi.org/10.1136/archdischild-2020-321441

7) Bugter, I. A. L., Janssen, L. C. E., Dieleman, J., Kramer, B. W., Andriessen, P., & Niemarkt, H. J. (2020). Introduction of less invasive surfactant administration (LISA), impact on diagnostic and therapeutic procedures in early life: A historical cohort study. BMC Pediatrics, 20, Article 421. https://doi.org/10.1186/s12887-020-02325-0