UK COLLABORATIVE RANDOMIZED TRIAL OF NEONATAL EXTRACORPOREAL MEMBRANE-OXYGENATION

Background Extracorporeal membrane oxygenation (ECMO) is a complex and expensive technology that can be used to provide temporary support du ring respiratory failure. Its value for mature newborn infants is cont roversial because of varying interpretation of the available evidence. We undertook a collaborative trial throughout the UK to assess whethe r a policy of referral for ECMO has a beneficial effect on survival to 1 year without severe disability in comparison with conventional mana gement. Methods Between 1993 and 1995, 185 mature (gestational age at birth greater than or equal to 35 weeks, birthweight greater than or e qual to 2 kg) newborn infants with severe respiratory failure (oxygena tion index greater than or equal to 40) were enrolled from 55 hospital s in a randomised comparison of either referral to one of five special ist centres for consideration of ECMO or continued intensive conventio nal management at the original hospital. The most common diagnoses wer e persistent pulmonary hypertension due to meconium aspiration, congen ital diaphragmatic hernia, isolated persistent fetal circulation, seps is, and idiopathic respiratory distress syndrome. Of the infants alloc ated ECMO, 84% received this support. Recruitment to the trial was sto pped early (November, 1995) by the trial steering committee on the adv ice of the independent data-monitoring committee, because the data acc umulated showed a clear advantage with ECMO, 124 children were enrolle d before December, 1994; those who survived to 1 year of age have unde rgone neurological assessment at that age (by one of three development al paediatricians unaware of treatment allocation). Findings Overall, 81 (44%) infants died before leaving hospital, and two are known to ha ve died later. Death rates differed between the two trial groups; 30 o f 93 infants allocated ECMO died compared 54 of 92 allocated conventio nal care. The relative was 0 . 55 (95% CI 0 . 39-0 . 77; p=0 . 0005), which is equivalent to one extra survivor for every three to four infa nts allocated ECMO. The difference in survival applied irrespective of the primary diagnosis, disease severity, and type of referral centre. The benefit of ECMO was also found for the primary outcome measure of death or disability at 1 year (among 124 children enrolled before Dec ember, 1994). One child in each group has severe disability (overall G riffiths' developmental quotient <50, or untestable), and 16 (ten ECMO , six conventional management) have impairments with a lesser degree o f disability. Interpretation These preliminary results demonstrate the clinical effectiveness of a well-staffed and organised neonatal ECMO service. ECMO support should be actively considered for neonates with severe but potentially reversible respiratory failure.