Purpose-This paper describes the methodology of an ongoing clinical trial of prone positioning in pediatric patients with acute lung injury (ALI). Nonrandomized studies suggest that prone positioning improves oxygenation in patients with ALI/ARDS without the risk of serious iatrogenic injury. It is not known if these improvements in oxygenation result in improvements in clinical outcomes. A clinical trial was needed to answer this question.
Materials and Methods-The pediatric prone study is a multi-center, randomized, non-crossover, controlled clinical trial. The trial is designed to test the hypothesis that at the end of 28 days, children with ALI treated with prone positioning will have more ventilator free days than children treated with supine positioning. Secondary endpoints include the time to recovery of lung injury, organ failure free days, functional outcome, adverse events, and mortality from all causes. Pediatric patients, 42 weeks post-conceptual age to 18 years of age, are enrolled within 48 hours of meeting ALI criteria. Patients randomized to the prone group are positioned prone within 4 hours of randomization and remain prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days. Both groups are managed according to ventilator protocol, extubation readiness testing, and sedation protocols and hemodynamic, nutrition and skin care guidelines.