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We examined the effect on survival of prone positioning as an early and continuous treatment in ARDS patients already treated with protective ventilation.Open randomized controlled trial in 17 medical-surgical ICUs.Forty mechanically ventilated patients with early and refractory ARDS despite protective ventilation in the supine position.Patients were randomized to remain supine or be moved to early (within 48 h) and continuous (≥ 20 h/day) prone position until recovery or death. The trial was prematurely stopped due to a low patient recruitment rate.Clinical characteristics, oxygenation, lung pressures, and hemodynamics were monitored. Need for sedation, complications, length of MV, ICU, and hospital stays, and outcome were recorded. PaO2/FIO2 tended to be higher in prone than in supine patients after 6 h (202 ± 78 vs. 165 ± 70 mmHg); this difference reached statistical significance on day 3 (234 ± 85 vs. 159 ± 78). Prone-related side effects were minimal and reversible. Sixty-day survival reached the targeted 15% absolute increase in prone patients (62% vs. 47%) but failed to reach significance due to the small sample.Our study adds data that reinforce the suggestion of a beneficial effect of early continuous prone positioning on survival in ARDS patients.