Accounting for deaths in neonatal trials: is there a correct approach?

[From Introduction] The Disability and Perinatal Care report published by the National Perinatal Epidemiology Unit and Oxford Regional Health Authority in 1994 emphasised that data on the neurodevelopmental outcomes of neonates requiring intensive care should be formally collected.1 Over the last 40 years, survival rates of high-risk infants have improved but these have not been matched with parallel improvements in neurodevelopmental outcomes.2–4 Consequently, the focus of neonatal care has shifted increasingly towards reducing long-term morbidity and neurodevelopmental impairment.1 2 Improved long-term neurodevelopment is now considered the ‘Holy Grail’ in neonatology.1 5 These developments have led to a change in focus of perinatal trials, which have moved away from survival as the primary outcome towards using long-term functional outcomes.2 This has raised the question of how to deal with deaths in those trials where neurodevelopmental impairment is of primary interest.