PT  - JOURNAL ARTICLE
AU  - Goldbart, Aviv
AU  - Golan-Tripto, Inbal
AU  - Pillar, Giora
AU  - Levnat-Levanon, Galit
AU  - Efrati, Ori
AU  - Spiegel, Ronen
AU  - Lubetzky, Ronit
AU  - Lavie, Moran
AU  - Carmon, Lior
AU  - Mizrahi, Mark
AU  - Nachum, Amit
TI  - A phase-III multicenter, randomized, double-blind, controlled trial of high-dose inhaled nitric oxide in infants with acute bronchiolitis.
AID  - 10.1183/13993003.congress-2018.PA4642
DP  - 2018 Sep 15
TA  - European Respiratory Journal
PG  - PA4642
VI  - 52
IP  - suppl 62
4099  - https://publications.ersnet.org//content/52/suppl_62/PA4642.short
4100  - https://publications.ersnet.org//content/52/suppl_62/PA4642.full
SO  - Eur Respir J2018 Sep 15; 52
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).