Laryngeal Mask Airway for Surfactant Administration in Neonates: A Randomized, Controlled Trial - 22/11/17

Doi : 10.1016/j.jpeds.2017.09.068

Kari D. Roberts, MD ^1,^* , Roland Brown ², Andrea L. Lampland, MD ^1,³, Tina A. Leone, MD ⁴, Kyle D. Rudser, PhD ², Neil N. Finer, MD ⁵, Wade D. Rich, RRT, CCRC ⁶, T. Allen Merritt, MD ⁷, Adam J. Czynski, DO ⁷, Julie M. Kessel, MD ⁸, Sajani M. Tipnis, MD ⁹, Erin C. Stepka, MD ¹, Mark C. Mammel, MD ^1,³
¹ Department of Pediatrics, University of Minnesota, Minneapolis, MN
² Department of Biostatistics, University of Minnesota, Minneapolis, MN
³ Department of Pediatrics, Children's Minnesota, St. Paul, MN
⁴ Department of Pediatrics, Columbia University, New York, NY
⁵ Department of Pediatrics, University of California-San Diego, San Diego, CA
⁶ Department of Pediatrics, Sharp Mary Birch, San Diego, CA
⁷ Department of Pediatrics, Loma Linda University, Loma Linda, CA
⁸ Department of Pediatrics, University of Wisconsin-Madison, Madison, WI
⁹ Department of Pediatrics, University of Mississippi, Jackson, MS

^*Reprint requests: Kari D. Roberts, MD, Department Pediatrics, University of Minnesota Masonic Children's Hospital, 2450 Riverside Ave, MB636, Minneapolis, MN 55454.Department PediatricsUniversity of Minnesota Masonic Children's Hospital2450 Riverside Ave, MB636MinneapolisMN55454

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Abstract

Objective

To determine if preterm infants with moderate respiratory distress syndrome on continuous positive airway pressure (CPAP) who received surfactant via a laryngeal mask airway (LMA) would have a decreased rate of intubation and mechanical ventilation compared with those on CPAP who did not receive surfactant.

Study design

In this prospective, multicenter, randomized controlled trial, 103 premature infants 28^0/7-35^6/7 weeks gestation, ≥1250 g and ≤36 hours old on CPAP requiring fraction of inspired oxygen 0.30-0.40 were assigned to receive surfactant administered through an LMA then placed back on CPAP (LMA group) or maintained on CPAP with no surfactant administered (control group). The primary outcome was treatment failure necessitating intubation and mechanical ventilation in the first 7 days of life.

Results

Surfactant administration through an LMA (n = 50) significantly decreased the rate of intubation and mechanical ventilation compared with controls (n = 53): 38% vs 64%, respectively, OR 0.30 (95% CI 0.13, 0.70), P = .006, number needed to treat: 4). There were no serious adverse events associated with placement of the LMA or surfactant administration.

Conclusions

In premature neonates with moderate respiratory distress syndrome, surfactant administered through an LMA decreased the rate of intubation and mechanical ventilation. This intervention may have significant impact on clinical care in both high and low resource settings.

Trial registration

ClinicalTrials.gov: NCT01116921.

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Keywords : respiratory distress syndrome, intubation, preterm, infant

Abbreviations : bpm, CPAP, ETT, FiO₂, LMA, NICU, RDS, SpO₂

Plan

Supported by grants from the Minnesota Medical Foundation, Children's Hospital Association, supporting Children's Minnesota, and the Clinical and Translational Sciences Institute (University of Minnesota NCATS award UL1TR000114). Support for Curosurf provided by Chiesi USA, Inc, support for LMAs provided by LMA North America, support for PediCaps provided by Covidien, and support for Neo-Verso Fluid/Access Catheters provided by CareFusion. The authors declare no conflicts of interest.