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.
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