Prone positioning and high-frequency oscillatory ventilation in early paediatric acute respiratory distress syndrome (PROSpect): an international, two-by-two factorial, response-adaptive, phase 3, randomised controlled trial.
Martha A Q Curley, Martin C J Kneyber, Ira M Cheifetz et al.
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In 30 seconds
PROSpect was an international, two-by-two factorial, phase 3 randomised controlled trial comparing prone with supine positioning and high-frequency oscillatory ventilation (HFOV) with conventional mechanical ventilation in children with early, moderate-to-severe paediatric acute respiratory distress syndrome. Across 75 paediatric intensive care units in 18 countries, 424 patients were enrolled before the trial stopped early for futility and slow recruitment. Neither intervention improved ventilator-free days through day 28: median days were 17·9 versus 17·4 for prone versus supine positioning and 17·3 versus 18·0 for HFOV versus conventional ventilation.
Key findings
- Prone and supine positioning showed no significant difference in ventilator-free days: median 17·9 days [IQR 8·9-21·3] versus 17·4 days [6·4-21·9].
- HFOV and conventional ventilation showed no significant difference in ventilator-free days: median 17·3 days [5·7-21·6] versus 18·0 days [9·9-21·5].
- Day-28 mortality was 41 (10%) patients, with no differences between groups.
- Airway obstruction and stage 2 or worse pressure injuries were more frequent with prone positioning; haemodynamic instability was more frequent with HFOV.
Why it matters
The trial addresses two interventions used amid uncertainty and practice variability in paediatric ARDS. Its findings provide no evidence that either strategy improves ventilator-free days when used as a first-line approach in early, moderate-to-severe disease, while identifying adverse events that differed by intervention. These results help frame the balance between expected benefit and potential harm.
What to keep in mind
The trial stopped early after 424 of 600 planned patients were recruited because of futility and slow enrolment. Interventions could not be masked.