Interpreting the clinical trials of extracorporeal membrane oxygenation in the treatment of persistent pulmonary hypertension of the newborn

Abstract

We review the findings of prospective randomized controlled clinical trials which have compared the efficacy of extracorporeal membrane oxygenation (ECMO) with conventional ventilator-based therapy (CT) in the treatment of severe persistent pulmonary hypertension of the newborn (PPHN). Initial trials in Michigan and Boston were non-conventional in their design, conduct and analysis; as a result their interpretation proved to be highly controversial. We review the relevant statistical issues and, in their light, discuss the implications of a third trial with a more conventional randomized design which has recently been completed in the UK.