Extracorporeal Membrane Oxygenation and Conventional Medical Therapy in Neonates With Persistent Pulmonary Hypertension of the Newborn: A Prospective Randomized Study

TLDR

The study compared ECMO and conventional medical therapy in newborns with severe persistent pulmonary hypertension, with groups matched for illness severity and ventilator support. A randomized trial enrolled 39 infants at high risk of death, halted after four deaths in the conventional group, and then treated the next 20 infants with ECMO. ECMO treatment yielded a 97 % survival rate (28 of 29) versus 60 % (6 of 10) with conventional therapy (P < .05).

Abstract

Thirty-nine newborn infants with severe persistent pulmonary hypertension and respiratory failure who met criteria for 85% likelihood of dying were enrolled in a randomized trial in which extracorporeal membrane oxygenation (ECMO) therapy was compared with conventional medical therapy (CMT). In phase I, 4 of 10 babies in the CMT group died and 9 of 9 babies in the ECMO group survived. Randomization was halted after the fourth CMT death, as planned before initiating the study, and the next 20 babies were treated with ECMO (phase II). Of the 20, 19 survived. All three treatment groups (CMT and ECMO in phase I and ECMO, phase II) were comparable in severity of illness and mechanical ventilator support. The overall survival of ECMO-treated infants was 97% (28 of 29) compared with 60% (6 of 10) in the CMT group (P less than .05).