ABSTRACT

I. BACKGROUND The mortality rate among infants with severe newborn respiratory failure was 80% or higher for many years. An alternative treatment, extracorporeal membrane oxygenation (ECMO), was introduced in 1977. Enough experience with individual cases had been gained by 1982 to undertake a randomized clinical trial. The potential existed for ECMO to lead to a survival rate of 80 % or more, but it was not known if this high a success rate could be achieved in a clinical trial on infants with well-defined entry criteria. The possibility of bleeding and other adverse effects existed since ECMO is essentially a heartlung machine, and its use involves the surgical bypass of both the heart and lungs.