Abstract
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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | e304-e315 |
| Journal | Pediatric Critical Care Medicine |
| Volume | 14 |
| Issue number | 7 |
| DOIs | |
| State | Published - 2013 |
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Keywords
- Cardiac arrest
- In hospital
- Mortality
- Multicenter
- Out of hospital
- Outcome
- Pediatric
- Randomized controlled trial
- Targeted temperature control
- Therapeutic hypothermia
- Therapeutic normothermia
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
- Critical Care and Intensive Care Medicine
Cite this
Rationale, timeline, study design, and protocol overview of the therapeutic hypothermia after pediatric cardiac arrest trials. / Moler, Frank W.; Silverstein, Faye S.; Meert, Kathleen L.; Clark, Amy E.; Holubkov, Richard; Browning, Brittan; Slomine, Beth S; Christensen, James R; Dean, J. Michael.
In: Pediatric Critical Care Medicine, Vol. 14, No. 7, 2013, p. e304-e315.Research output: Contribution to journal › Article
}
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
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
UR - http://www.scopus.com/inward/record.url?scp=84903678095&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84903678095&partnerID=8YFLogxK
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 -