RT Journal Article
SR Electronic
T1 A phase-III multicenter, randomized, double-blind, controlled trial of high-dose inhaled nitric oxide in infants with acute bronchiolitis.
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP PA4642
DO 10.1183/13993003.congress-2018.PA4642
VO 52
IS suppl 62
A1 Goldbart, Aviv
A1 Golan-Tripto, Inbal
A1 Pillar, Giora
A1 Levnat-Levanon, Galit
A1 Efrati, Ori
A1 Spiegel, Ronen
A1 Lubetzky, Ronit
A1 Lavie, Moran
A1 Carmon, Lior
A1 Mizrahi, Mark
A1 Nachum, Amit
YR 2018
UL https://publications.ersnet.org//content/52/suppl_62/PA4642.abstract
AB Acute viral bronchiolitis is the most common lower respiratory infection in early infancy and a leading cause of infant hospitalization. The treatment of bronchiolitis is largely supportive. Inhaled nitric oxide (NO) has pulmonary vasodilatory properties and has been approved for the treatment of persistent pulmonary hypertension of the newborn. Furthermore, preclinical studies show that high-dose NO possesses anti-bacterial and anti-viral properties. In a recent pilot study, we have shown safety and tolerability of high-dose NO (160 ppm) in infants with moderately severe bronchiolitis. In this study, we are conducting a randomized, multicenter, double-blind, controlled pivotal trial comparing the efficacy of intermittent 160 ppm NO (30min, 5 times/day, up to 5 days) with standard supportive care (O2/air) in 94 infants (0-12 months old, clinical score 7-10, requiring >24hr hospitalization) admitted to 10 hospitals across Israel. All subjects receive standard of care treatment. The primary outcome measure is the length of hospital stay (LOS). The secondary outcome measures are time to reach clinical score of 5 and below (Modified Tal score) and time to reach O2 saturation of 92% and above in room air. Adverse events (AE’s) and NO-related AE’s including methemoglobin and nitrogen dioxide levels are closely monitored. At the time of submission, the trial is ongoing with 46 out of 94 subjects enrolled at 5 sites. We anticipate demonstrating efficacy by reducing LOS and improving clinical symptoms in infants treated with NO. We predict completing the trial by April 30, 2018 and present final results at the next 2018 ERS International meeting, Paris.FootnotesCite this article as: European Respiratory Journal 2018 52: Suppl. 62, PA4642.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).