PROSpect trial: prone positioning and HFOV did not shorten ventilation in children with PARDS
A phase 3 trial in 424 children with moderate-to-severe PARDS found no difference in ventilator-free days to day 28 for prone positioning or HFOV. The trial was stopped early.
The international phase 3 randomised trial PROSpect, published in The Lancet, compared 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 (PARDS). It was run in 75 paediatric intensive care units in 18 countries. The trial was stopped early for futility and slow enrolment after 424 of 600 planned patients were recruited doi.org
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Design and primary outcome
Eligible patients were aged 2 weeks to 20 years and had been intubated and mechanically ventilated for less than 96 hours before meeting criteria for moderate-to-severe PARDS. Between May 1, 2019 and Jan 13, 2026, 1045 patients were eligible for enrolment. Patients were randomly assigned in a two-by-two factorial design: 126 to supine positioning with conventional ventilation, 130 to prone positioning with conventional ventilation, 90 to supine positioning with HFOV, and 78 to prone positioning with HFOV. Masking was not possible given the nature of the interventions doi.org
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The primary outcome was ventilator-free days through to day 28. There were no significant differences between prone and supine positioning, or between HFOV and conventional ventilation. By day 28, 41 patients (10%) had died, with no differences between groups doi.org
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Adverse events
Plugging or obstruction of the artificial airway occurred more often with prone than with supine positioning: 14 events in 12 (6%) of 188 patients versus three events in three (2%) of 197 patients. Stage 2 or worse immobility-related pressure injuries were also more frequent with prone positioning: 12 (6%) versus two (1%) doi.org
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Haemodynamic instability was more frequent with HFOV than with conventional ventilation: 41 events in 19 (13%) of 141 patients versus 38 events in 22 (9%) of 244 patients. One serious adverse event, an unwitnessed self-extubation followed by cardiopulmonary arrest, occurred in a patient in the prone and conventional ventilation group doi.org
The Lancetdoi.orgOpen source ↗.
The authors state that they found no evidence to support prone positioning or HFOV as first-line strategies to improve ventilator-free days in this population, and that routine use is not recommended. According to the study team, the findings do not cover the use of either approach as rescue treatment in selected patients doi.org
The Lancetdoi.orgOpen source ↗.
