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. Author manuscript; available in PMC: 2014 Jan 1.
Published in final edited form as: Pediatr Crit Care Med. 2013 Jan;14(1):19–26. doi: 10.1097/PCC.0b013e31825b860b

Table 2.

Protocol changes during the vanguard phase

Date Protocol Amendment Days to IRB approval
Median (range)
6/29/2009 Simplification of protocol to decrease data collection and clarify temperature monitoring 36 (10–127)
10/22/2009 Exclusion criterion changed to allow THAPCA- eligible subjects to be co-enrolled in other select interventional studies 34 (7–104)
12/28/2009 Exclusion criterion changed to allow children with previous cardiac arrests to be enrolled into the trial. 29 (11–77)
5/11/2010 Incorporation of a family brochure and short consent form. 43 (24–176)