Do the definitions for trial conflict with current WHO and national paediatric guidelines and thus preclude a control arm (low volume maintenance only)?
WHO currently only recommends rapid fluid resuscitation for the treatment of advanced shock (that is defined as the presence of cold hands or feet plus both a weak rapid pulse and capillary refill time >3 seconds) in children. Validation of these signs using our paediatric surveillance data in Kilifi indicates that shock would rarely diagnosed and mortality extremely high in that group. This was also confirmed when these signs were prospectively validated in Brazil. The WHO definition approximates to children enrolled into Group B arm of the trial (decompensated shock) who all receive fluid boluses at admission. It also approximates to the ‘rescue criteria’ for children allocated to control. We therefore see no conflict with current recommendations. Finally, if the admitting doctor feels that the patient would better off not enrolling than enrolling into the trial (ie clinical equipoise is not supported) then they may chose not to enrol the child into the trial.
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