Pediatric critical care clinicians often resort to rescue interventions, including prone positioning and/or high frequency oscillatory ventilation (HFOV) for refractory hypoxemic respiratory failure. However, no clinical trial has shown outcome benefits for either of these approaches for pediatric ARDS. While adult data for prone positioning for severe ARDS demonstrates improved survival, data in the adult ARDS population shows that HFOV is associated with worse outcomes. Without a pediatric randomized controlled trial of these two management strategies, pediatric clinicians are left to decide their approach to severe PARDS based on clinical experience and/or extrapolation form the adult-based data.
The PRone and OScillation Pediatric Clinical Trial (PROSpect) is designed to study the effects of prone positioning and HFOV for PARDS using a 2X2 factorial adaptive randomized controlled clinical trial. The primary outcome variable is ventilator-free days (VFD). Secondary outcomes include organ-failure free days, PICU and hospital length of stay, in-hospital and 90-day mortality, and post-discharge quality of life and emotional health. It is anticipated that about 1000 patients with severe PARDS will be enrolled from Pediatric Intensive Care Units children across North America, Europe, Asia, and Australia-New Zealand.