Table 2

Generic severity criteria of INC NAESS developed for use in neonates

Grade 1Grade 2Grade 3Grade 4Grade 5
MildModerateSevereLife threateningDeath
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no change in baseline age-appropriate behaviour * ; no change in baseline care or monitoring indicated . Moderate; resulting in minor changes of baseline age-appropriate behaviour * ; requiring minor changes in baseline care or monitoring .* Severe; resulting in major changes of baseline age-appropriate behaviour* or non-life-threatening changes in basal physiological processes†; requiring major change in baseline care or monitoring.*‡ Life threatening; resulting in life-threatening changes in basal physiological processes†; requiring urgent major change in baseline care. Death related to AE.
  • If the different factors of this scale result in conflicting severity grades, the highest grade should be reported. Italics indicate the differences with the adult generic severity criteria of CTCAE.

  • *Age-appropriate behaviour refers to oral feeding behaviour, voluntary movements and activity, crying pattern, social interactions and perception of pain.

  • †Basal physiological processes refer to oxygenation, ventilation, tissue perfusion, metabolic stability and organ functioning.

  • ‡Minor care changes constitute: brief, local, non-invasive or symptomatic treatments.

  • §Major care changes constitute: surgery, addition of long-term treatment, upscaling care level.

  • CTCAE, Common Terminology Criteria for Adverse Events.