Here are some genuine questions regarding design for a HIE trial. Hoping some of the more scientifically literate posters might be able to shine a light into the dim recesses of my mind.
I assume it would not be ethical to give a placebo to an infant in a life threatening situation. Correct?
So do half of the newborns receive the existing rapid cooling treatment? Is success of the drug/trial measured as outcomes vs the existing treatment?
Or could the trial designers say that there exists decades of data on the current treatment so everyone who agrees could receive the drug? The results them being compared to the known historical outcomes.
If the result of HIE is brain damage and impairment how long would you have to wait for a baby to grow into a child old enough to be measured for that resulting impairment. EG if a consequence of HIE was delayed or poor verbal abilities would you have to wait say 18 months for that to become evident?
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