Randomized Trial of Surfactant Therapy via Laryngeal Mask Airway Versus Brief Tracheal Intubation in Neonates Born Preterm - 14/03/23
Abstract |
Objective |
To evaluate the possible noninferiority of surfactant administration via laryngeal mask airway (LMA) vs endotracheal tube (ETT) in avoiding the requirement for mechanical ventilation in preterm neonates with respiratory distress syndrome (RDS).
Study design |
This was a randomized controlled trial including infants born at 27 to 36 weeks of gestation, >800 g, diagnosed with RDS and receiving fraction of inspired oxygen 0.30-0.60 via noninvasive respiratory support. Infants were randomized to surfactant via LMA (with atropine premedication) or ETT (InSuRE approach with atropine and remifentanil premedication). Primary outcome was failure of surfactant treatment to prevent the need for mechanical ventilation.
Results |
Patients were randomized, 51 to LMA and 42 to the ETT group. Both groups had similar baseline characteristics, with birth weights ranging from 810 to 3560 g. Failure rate was 29% in the ETT group and 20% in the LMA group (P = .311). This difference was due to early failures (within 1 hour), with 12.5% in the ETT group and 2% in the LMA group (P = .044). Surfactant therapy via LMA was non-inferior to administration via ETT; failure risk difference −9.0% (CI –∞ to 5.7%). Efficacy in decreasing fraction of inspired oxygen, number of surfactant doses administered, time to wean off all respiratory support, rates of adverse events, and outcomes including pneumothorax and BPD diagnosis did not differ between groups.
Conclusions |
Surfactant therapy via LMA was noninferior to administration via ETT and it decreased early failures, possibly by avoiding adverse effects of premedication, laryngoscopy, and intubation. These characteristics make LMA a desirable conduit for surfactant administration.
Trial registration |
ClinicalTrials.gov, NCT02164734.
Le texte complet de cet article est disponible en PDF.Key words : respiratory distress syndrome, premedication, remifentanil, infant, newborn, laryngeal mask, supraglottic airway devices
Abbreviations : BPD, CPAP, ETT, FiO2, InSuRE, LISA, LMA, MIST, NICU, NIPPV, RDS
Plan
| Initial implementation of this study was supported in part by a Neonatology fellowship educational grant from ONY, Inc. All the remaining funding was from the authors’ institution. ONY, Inc, had no input into the design, conduct, analysis, or presentation of the study results, nor in the writing or publishing of this manuscript, and they did not receive advance notification of the results. C.P. declares he is on the Speakers’ Bureau of Chiesi Farmaceutici. The other authors declare no conflicts of interest. |
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| Portions of this study were presented as oral abstracts during the Pediatric Academic Societies' meeting, held virtually on May 1-5, 2020 from Philadelphia, PA, USA, and during the American Academy of Pediatrics Virtual National Conference & Exhibition, on October 2-5, 2020. |
Vol 254
P. 17 - mars 2023 Retour au numéro
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