1. Inhaled PGE1 in neonates with hypoxemic respiratory failure: two pilot feasibility randomized clinical trials.
- Author
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Sood, Beena G, Keszler, Martin, Garg, Meena, Klein, Jonathan M, Ohls, Robin, Ambalavanan, Namasivayam, Cotten, C Michael, Malian, Monica, Sanchez, Pablo J, Lakshminrusimha, Satyan, Nelin, Leif D, Van Meurs, Krisa P, Bara, Rebecca, Saha, Shampa, Das, Abhik, Wallace, Dennis, Higgins, Rosemary D, Shankaran, Seetha, and Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network
- Subjects
Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network ,Humans ,Persistent Fetal Circulation Syndrome ,Respiratory Insufficiency ,Alprostadil ,Vasodilator Agents ,Aerosols ,Treatment Outcome ,Administration ,Inhalation ,Feasibility Studies ,Pilot Projects ,Sample Size ,Patient Selection ,Time Factors ,Infant ,Newborn ,United States ,Early Termination of Clinical Trials ,Hypoxia ,Lung ,Infant Mortality ,Clinical Research ,Perinatal Period - Conditions Originating in Perinatal Period ,Clinical Trials and Supportive Activities ,Pediatric ,Cardiovascular System & Hematology ,General & Internal Medicine ,Cardiorespiratory Medicine and Haematology ,Clinical Sciences - Abstract
BackgroundInhaled 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.MethodsTwo 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
- Published
- 2014