Laryngeal Mask Airway for Surfactant Administration in Neonates: A Randomized, Controlled Trial

Kari D Roberts; Roland Brown; Andrea L Lampland; Tina A Leone; Kyle D Rudser; Neil N Finer; Wade D Rich; T Allen Merritt; Adam J Czynski; Julie M Kessel; Sajani M Tipnis; Erin C Stepka; Mark C Mammel

doi:10.1016/j.jpeds.2017.09.068

Laryngeal Mask Airway for Surfactant Administration in Neonates: A Randomized, Controlled Trial

J Pediatr. 2018 Feb:193:40-46.e1. doi: 10.1016/j.jpeds.2017.09.068. Epub 2017 Nov 22.

Authors

Affiliations

¹ Department of Pediatrics, University of Minnesota, Minneapolis, MN. Electronic address: rober694@umn.edu.
² Department of Biostatistics, University of Minnesota, Minneapolis, MN.
³ Department of Pediatrics, University of Minnesota, Minneapolis, MN; 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.
¹⁰ Department of Pediatrics, University of Minnesota, Minneapolis, MN.

PMID: 29174079
DOI: 10.1016/j.jpeds.2017.09.068

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.

Keywords: infant; intubation; preterm; respiratory distress syndrome.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Continuous Positive Airway Pressure / adverse effects
Continuous Positive Airway Pressure / methods*
Continuous Positive Airway Pressure / statistics & numerical data
Female
Humans
Infant, Newborn
Infant, Premature
Intubation, Intratracheal / statistics & numerical data
Laryngeal Masks*
Male
Prospective Studies
Pulmonary Surfactants / administration & dosage*
Respiratory Distress Syndrome, Newborn / therapy*
Treatment Failure
Treatment Outcome

Substances

Pulmonary Surfactants

Associated data

ClinicalTrials.gov/NCT01116921