Table 1.
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.