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Inhaled PGE1 in neonates with hypoxemic respiratory failure
Two pilot feasibility randomized clinical trials
Sood, B. G., Keszler, M., Garg, M., Klein, J. M., Ohls, R., Ambalavanan, N., Cotten, C. M., Malian, M., Sanchez, P. J., Lakshminrusimha, S., Nelin, L. D., Van Meurs, K. P., Bara, R., Saha, S., Das, A., Wallace, D., Higgins, R. D., & 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
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
