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Rationale, timeline, study design, and protocol overview of the therapeutic hypothermia after pediatric cardiac
Frank W Moler1, Faye S Silverstein, Kathleen L Meert
11Department 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.
Insights
Planning the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials took over a decade. This detailed overview of the pediatric cardiac arrest study may aid future federally supported clinical trials.
Area of Science:
- Pediatric critical care medicine
- Cardiovascular research
- Clinical trial methodology
Background:
- Pediatric cardiac arrest presents significant survival challenges.
- Therapeutic hypothermia is a potential intervention for improving outcomes post-cardiac arrest.
- Standardized trial design is crucial for evaluating interventions in critically ill children.
Purpose of the Study:
- To outline the rationale, timeline, study design, and protocol for the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials.
- To provide a comprehensive overview of the planning and operationalization of multicenter pediatric cardiac arrest trials.
- To share lessons learned for future investigator-initiated, federally funded clinical research.
Main Methods:
- Multicenter randomized controlled trials involving children (48 hours to 18 years) who achieved return of circulation after cardiac arrest.
- Trials conducted in pediatric intensive care units and cardiac ICUs across the United States and Canada.
- Interventions compared therapeutic hypothermia versus therapeutic normothermia, with guardian consent.
Main Results:
- The planning and operationalization phase for the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials spanned 7 years (2002-2009).
- Feasibility and protocol development were supported by National Institute of Child Health and Human Development grants (R21, R34).
- Infrastructure was provided by the Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network; funding by NHLBI U01 awards.
Conclusions:
- The complete process, from planning to execution, for these trials is estimated to take over a decade.
- The study highlights the utility of clinical research networks and planning grants in large-scale pediatric trials.
- This detailed report offers valuable insights for designing and implementing future investigator-initiated, federally supported clinical trials in pediatric critical care.
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.
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