Inhaled PGE1 in neonates with hypoxemic respiratory failure Two pilot feasibility randomized clinical trials

BACKGROUND: Inhaled nitric oxide (INO), a selective pulmonary vasodilator, has revolutionized the treatment of neonatal hypoxemic respiratory failure (NHRF). However, there is lack of sustained improvement in 30 to 46% of infants. Aerosolized prostaglandins I2 (PGI2) and E1 (PGE1) have been reported to be effective selective pulmonary vasodilators. The objective of this study was to evaluate the feasibility of a randomized controlled trial (RCT) of inhaled PGE1 (IPGE1) in NHRF. METHODS: Two pilot multicenter phase II RCTs are included in this report. In the first pilot, late preterm and term neonates with NHRF, who had an oxygenation index (OI) of >/=15 and

Sood, B. G., Keszler, M., Garg, M., Klein, J. M., Ohls, R., Ambalavanan, N., ... Shankaran, S. (2014). Inhaled PGE1 in neonates with hypoxemic respiratory failure: Two pilot feasibility randomized clinical trials. Trials, 15, e486. https://doi.org/10.1186/1745-6215-15-486