Prone positioning and oscillatory ventilation did not add ventilator-free days in paediatric ARDS

Design

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

Population

424 children aged 2 weeks to 20 years with early moderate-to-severe paediatric ARDS

Primary outcome

Ventilator-free days to day 28

Effect

Prone vs supine: shift 0.0 days (−0.8 to 1.0); HFOV vs conventional: −0.3 days (−1.5 to 0.5)

PROSpect was an international two-by-two factorial phase 3 trial in 75 paediatric intensive care units across 18 countries, published in the Lancet on 31 October. Children aged two weeks to 20 years with early moderate-to-severe paediatric ARDS were randomised to prone or supine positioning, and to high-frequency oscillatory ventilation (HFOV) or conventional ventilation.

It stopped early for futility and slow recruitment at 424 of 600 planned patients. Ventilator-free days to day 28 were the same with prone or supine positioning (median about 18 days in each) and with HFOV or conventional ventilation. Mortality at 28 days was 10%, with no differences between groups.

Harms were not neutral. Prone positioning brought more endotracheal tube blockage and more stage 2 or worse pressure injuries. HFOV brought more haemodynamic instability. One child in a prone group had an unwitnessed self-extubation followed by cardiac arrest.

This argues against prone positioning and HFOV as routine first-line strategies in children, unlike adult ARDS where proning has trial support. It does not address their use as rescue in refractory hypoxaemia.

• Do not routinely prone children with early moderate-to-severe ARDS; it did not shorten ventilation.
• Do not use HFOV as a first-line mode; it caused more haemodynamic instability.
• If proning a child, check tube patency often and protect pressure areas.
• Do not extrapolate adult proning evidence to children.
• Rescue use in refractory hypoxaemia was not tested.

Why it matters

It challenges the practice of borrowing adult proning evidence for children.

Don't overread it

The trial stopped early; it cannot exclude a small benefit, and it did not test rescue use.

The statistics, in plain English

The shift in ventilator-free days for prone versus supine was 0.0 days (95% CI −0.8 to 1.0), and for HFOV −0.3 days (−1.5 to 0.5). Both intervals sit tightly around zero, so any benefit missed is likely to be less than a day. Airway blockage was nearly five times more frequent with proning (rate ratio 4.83, 1.38 to 16.82).

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