ABSTRACT

This chapter discusses the structure and organisation of a specific neonatal trial that took place in the United Kingdom (UK) 1992–1994 and the practical and ethical difficulties in obtaining consent for this trial. Extra-corporeal Membrane Oxygenation (ECMO) is a form of lung-bypass. This technique oxygenates blood outside the body obviating the need for gas exchange in the lungs. Neonatal ECMO is most commonly used to support mature newborn infants. Prior to the UK collaborative ECMO trial, any fully mature newborn infant with a specific lung condition in which gaseous exchange was a problem despite full support via a ventilator could be considered for ECMO. The clinical conditions were such that the majority of infants would have been expected to develop the condition leading to respiratory failure only in the first 24 hours after birth, that is, they would not have been predicted prior to delivery.