Commentary on neonatal ECMO: a North American and Scandinavian perspective.

Randomized clinical trials have become the cornerstone of clinical decision making in neonatal medicine. The need to establish the safety and efficacy of different treatment regimens by means of an unbiased approach has led to the formation of state-agency supported and voluntary national and international networks. These neonatal networks have greatly facilitated the organization of randomized multicenter trials. Most studies aimed to evaluate specific treatment alternatives for common disorders (e.g. surfactant therapy for RDS and iv gammaglobulins for prevention of nosocomial infections are particularly well suited for a randomized clinical trial). However, appraisal of alternative therapies for rare conditions with excessive mortality and high risk for later sequelae is limited by a number of practical and ethical considerations. In view of the complexity of the problems involved it is hardly surprising that only one recent head-to-head trial of conventional therapy versus ECMO has to our knowledge been published (39). In this investigation 28 full-term infants fulfilling standard ECMO criteria were randomly assigned to be transported for ECMO or to receive conventional treatment available on-site. Fourteen of the 15 infants (93%) referred for ECMO survived compared with 7 of 13 (53%) treated conventionally. The long-term outcome was comparable in both groups. These data support previous reports of significantly better survival following ECMO treatment. However, the notion of > 80% mortality on continuation of conventional therapy in this critically ill population may need to be reassessed. HFO is today part of "conventional" therapy in many centers, surfactant is used routinely and a combination of NO and HFO is being evaluated in several clinical trials (57).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes