Eligible patients were randomly assigned in a 1:1 ratio to either therapeutic hypothermia or therapeutic normothermia. Randomization was performed with the use of permuted blocks stratified according to clinical center and age at entry (<2 years, 2 to <12 years, and ≥12 years).
Targeted temperature management was actively maintained for 120 hours in each group. Children who were assigned to therapeutic hypothermia were pharmacologically paralyzed and sedated, and a Blanketrol III temperature management unit (Cincinnati Sub-Zero) was used, with blankets applied anteriorly and posteriorly, to achieve and maintain a core temperature of 33.0°C (range, 32.0 to 34.0) for 48 hours. The children were then rewarmed over a period of 16 hours or longer to a target temperature of 36.8°C (range, 36.0 to 37.5); this temperature was actively maintained throughout the remainder of the 120-hour intervention period. Children who were randomly assigned to therapeutic normothermia received identical care except that the core temperature was actively maintained with the cooling unit at 36.8°C (range, 36.0 to 37.5) for 120 hours.
Dual monitoring of the central temperature (esophageal, rectal, or bladder temperature) and an automatic mode on the temperature management unit were used for all the patients. The probe connected to the cooling unit was designated to be the primary probe; the other probe was connected to the bedside monitor for safety backup. In three patients who received extracorporeal membrane oxygenation (ECMO) at the time of randomization, ECMO was used for temperature control. All other aspects of clinical care were determined by the clinical teams.
Moler F.W., Silverstein F.S., Holubkov R., Slomine B.S., Christensen J.R., Nadkarni V.M., Meert K.L., Clark A.E., Browning B., Pemberton V.L., Page K., Shankaran S., Hutchison J.S., Newth C.J., Bennett K.S., Berger J.T., Topjian A., Pineda J.A., Koch J.D., Schleien C.L., Dalton H.J., Ofori-Amanfo G., Goodman D.M., Fink E.L., McQuillen P., Zimmerman J.J., Thomas N.J., van der Jagt E.W., Porter M.B., Meyer M.T., Harrison R., Pham N., Schwarz A.J., Nowak J.E., Alten J., Wheeler D.S., Bhalala U.S., Lidsky K., Lloyd E., Mathur M., Shah S., Wu T., Theodorou A.A., Sanders RC J.r, & Dean J.M. (2015). Therapeutic Hypothermia after Out-of-Hospital Cardiac Arrest in Children. The New England journal of medicine, 372(20), 1898-1908.