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.
1Department of Pediatrics, University of Michigan, Ann Arbor, MI.
2Department of Pediatrics, Wayne State University, Detroit, MI.
3Department of Pediatrics, University of Utah, Salt Lake City, UT.
4Department of Neuropsychology, Kennedy Krieger Institute, Baltimore, MD.
5Department of Pediatric Rehabilitation Medicine, Kennedy Krieger Institute, Baltimore, MD.
ClinicalTrials.gov Identifiers: THAPCA-out-of-hospital (NCT00878644), THAPCA-in-hospital (NCT00880087); website: http://www.thapca.org/.
Supported, in part, by the Pediatric Emergency Care Applied Research Network (PECARN) from cooperative agreements U03MC00001, U03MC00003, U03MC00006, U03MC00007, and U03MC00008 and the Collaborative Pediatric Critical Care Research Network (CPCCRN) from cooperative agreements (U10HD500009, U10HD050096, U10HD049981, U10HD049945, U10HD049983, U10HD050012, and U01HD049934).
Dr. Moler received federal grants HD044955 from the National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); HD050531 from NIH, NICHD; and HL094345 from NIH, National Heart Lung Blood Institute (NHLBI). Dr. Dean received federal grant HL094339 from NIH, NHLBI. Drs. Silverstein, Meert, Clark, Holubkov, Browning, Slomine, and Christensen received funding from NIH.
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