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. Author manuscript; available in PMC: 2014 Mar 9.
Published in final edited form as: Pediatr Crit Care Med. 2013 Sep;14(7):e304–e315. doi: 10.1097/PCC.0b013e31828a863a

Table 1.

Timeline for Therapeutic Hypothermia After Pediatric Cardiac Arrest Trials

Year Key Events
2002 PECARN originates and adult therapeutic hypothermia RCTs published New England Journal of Medicine

2003 National Institute of Child Health and Human Development R21 Request for Applications Pediatric Cardiac
Arrest, Hypothermia RCT planning grant (HD044955) (July 2003) awarded

2004–2006 Cohort study conducted at 15 PECARN sites

2006 R34 (HD050531) awarded to support writing MOO (July 2006)

2006 Collaborative Pediatric Critical Care Research Network sites join PECARN sites to operationalize trials
  Protocol planning meeting in Washington, DC
  Other planning meetings in Toronto and Salt Lake City

2006 Prospective yield study at select sites using inclusion and exclusion criteria

2007 Draft MOO with “refined” protocol
  NHLBI contacted to submit application > ppg limit (1.5 M)
  Letter (5-page study overview) to directors NHLBI— approved

2008 R01s submitted (February 2008)
  Study section review and council approved
  Budget and study design modifications by NHLBI (November 2008)

2009 HL094345 and HL094339 awards received (March 2009)
  Institutional Review Board materials and contracts to sites (April 2009)
  Vanguard (half of sites) selection (June 2009)
  Training (August 2009)
  Enrollment begins per schedule (September 1, 2009)
  Data Safety and Monitoring Board created

2009 Vanguard site enrollment (September 2009–August 31, 2010)
  Exceeds feasibility (minimum) goal 50 cases and expected goal 75 cases
  Actual enrolled: 90 cases

2010 Funding approved to add second cohort of sites (September 2010)

2012 37 total sites and enrollment of 389 cases as of May 29, 2012

PECARN = Pediatric Emergency Care Applied Research Network, RCT = randomized controlled trials.