I wanted to ask a few questions regarding the protocol.
Firstly, building on Dr Webbe's question regarding termination of study, I can see this was determined utilising the O'Brien Fleming stopping boundaries. I wanted to ask what these boundaries are and how they inform continuation or termination of a study.
Secondly, in the secondary outcomes hypothermia was defined as an axillary temperature of < 36 degrees C. Locally we use a threshold of 36.5 degrees for hypothermia. Babies with a temperature of 36-36.6 degrees would not have been defined as hypothermic in your study. What was the reason for choosing a threshold of 36 degrees and do you feel this could have affected your results?
Finally, in the discussion section it mentions ways in which iKMC may be beneficial, one of these being 'more frequent monitoring of glucose levels.' Why would glucose monitoring be more frequent in the intervention group?
Many thanks and I look forward to hearing your responses!
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