TY - JOUR
T1 - Rationale, timeline, study design, and protocol overview of the therapeutic hypothermia after pediatric cardiac arrest trials
AU - Moler, Frank W.
AU - Silverstein, Faye S.
AU - Meert, Kathleen L.
AU - Clark, Amy E.
AU - Holubkov, Richard
AU - Browning, Brittan
AU - Slomine, Beth S.
AU - Christensen, James R.
AU - Dean, J. Michael
N1 - Publisher Copyright:
Copyright © 2013 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.
PY - 2013
Y1 - 2013
N2 - Objective: To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Design: Multicenter randomized controlled trials. Setting: Pediatric intensive care and cardiac ICUs in the United States and Canada. Patients: Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent. Interventions: Therapeutic hypothermia or therapeutic normothermia. Measurements and Main Results: From concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015. Conclusions: Over a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials.
AB - Objective: To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Design: Multicenter randomized controlled trials. Setting: Pediatric intensive care and cardiac ICUs in the United States and Canada. Patients: Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent. Interventions: Therapeutic hypothermia or therapeutic normothermia. Measurements and Main Results: From concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015. Conclusions: Over a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials.
KW - Cardiac arrest
KW - In hospital
KW - Mortality
KW - Multicenter
KW - Out of hospital
KW - Outcome
KW - Pediatric
KW - Randomized controlled trial
KW - Targeted temperature control
KW - Therapeutic hypothermia
KW - Therapeutic normothermia
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U2 - 10.1097/PCC.0b013e31828a863a
DO - 10.1097/PCC.0b013e31828a863a
M3 - Article
C2 - 23842585
AN - SCOPUS:84903678095
VL - 14
SP - e304-e315
JO - Pediatric Critical Care Medicine
JF - Pediatric Critical Care Medicine
SN - 1529-7535
IS - 7
ER -