Title: Accounting for deaths in neonatal trials: is there a correct approach?
Authors: Parekh, Shalin A.; Field, David J.; Johnson, Samantha; Juszczak, E.
Abstract: [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.