Prone positioning and oscillation did not help children with early ARDS

Design

International two-by-two factorial randomised phase 3 trial, stopped early

Population

424 children with early moderate-to-severe paediatric ARDS

Primary outcome

Ventilator-free days to day 28

Effect

Prone vs supine shift 0.0 days (95% CI −0.8 to 1.0); oscillation vs conventional −0.3 (−1.5 to 0.5)

PROSpect was a two-by-two factorial randomised trial in 75 paediatric intensive care units across 18 countries. Children aged 2 weeks to 20 years, ventilated for under 96 hours and meeting criteria for moderate-to-severe paediatric ARDS, were assigned to prone or supine positioning, and to high-frequency oscillatory or conventional ventilation. Median age was 3.3 years.

The trial stopped early for futility and slow recruitment after 424 of 600 planned children. Ventilator-free days to day 28 were almost identical whether children were prone or supine (median about 18 vs 17), and whether they had oscillation or conventional ventilation. Ten per cent died by day 28, with no difference between groups.

The harms were not neutral. Prone positioning was linked to about five times the rate of airway blockage and six times the rate of stage 2 or worse pressure injuries. Oscillation was linked to more haemodynamic instability.

Both strategies are widely used in children on extrapolation from adults. This trial gives no support for either as a first-line approach in early disease; they may still have a place as rescue in selected cases, which the trial did not test.

• Avoid routine first-line prone positioning in children with early moderate-to-severe ARDS outside a trial.
• Avoid routine first-line high-frequency oscillatory ventilation in the same group.
• If prone positioning is used, watch closely for tube blockage and protect pressure areas.
• Use lung-protective conventional ventilation as the default and review rescue options case by case.

Why it matters

It challenges an adult-derived practice that has spread in paediatric intensive care without evidence of benefit.

Don't overread it

The trial tested first-line use in early disease; it does not settle rescue use in refractory hypoxaemia.

The statistics, in plain English

The Hodges-Lehmann shift estimates the difference in median ventilator-free days; 0.0 days (95% CI −0.8 to 1.0) for prone means any true benefit is probably less than one day. Stopping early means the trial had less power than planned, but the estimates sit so close to zero that a large missed benefit is unlikely. The harm rates are based on small numbers, hence wide intervals.

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