Pediatr Crit Care Me
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Pediatr Crit Care Me · Jan 2013
Review Meta AnalysisSelective decontamination of the digestive tract in critically ill children: systematic review and meta-analysis.
We examined the impact of selective decontamination of the digestive tract on morbidity and mortality in critically ill children. ⋯ In the four available pediatric randomized controlled trials, selective decontamination of the digestive tract significantly reduced the number of children who developed pneumonia.
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Pediatr Crit Care Me · Jan 2013
Randomized Controlled Trial Multicenter StudyTherapeutic hypothermia after pediatric cardiac arrest trials: the vanguard phase experience and implications for other trials.
To determine whether an 18-month vanguard phase, in the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials, confirmed study feasibility and patient safety, a prerequisite to continued funding by the sponsor. ⋯ The Therapeutic Hypothermia after Pediatric Cardiac Arrest vanguard phase proved beneficial for the investigators and funding agency. Because complex multicenter trials are rarely ready to launch when grant funds are received, the vanguard allowed time to refine the protocol and recruitment approaches. Competition for vanguard positions led to expedient Institutional Review Board and subcontract completion. Early success and sustained momentum contributed to recruitment at or above goals. Financial risks to the sponsor were minimized by tying funding for the full trial to achieving prespecified milestones. A vanguard phase may be a desirable strategy for the successful conduct of other complex clinical trials.