Prone positioning and HFOV did not increase ventilator-free days in early paediatric ARDS

Design

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

Population

424 children with early moderate-to-severe paediatric ARDS in 75 PICUs

Primary outcome

Ventilator-free days to day 28

Effect

Prone vs supine 17.9 vs 17.4 days (shift 0.0, 95% CI −0.8 to 1.0); HFOV vs conventional 17.3 vs 18.0 (−0.3, −1.5 to 0.5)

PROSpect randomised children aged 2 weeks to 20 years with early moderate-to-severe paediatric ARDS, in 75 intensive care units across 18 countries, in a two-by-two factorial design: prone or supine, and 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 did not differ between prone and supine (median 17.9 vs 17.4 days) or between HFOV and conventional ventilation (17.3 vs 18.0). Day-28 mortality was 10%, with no group differences.

Harms did differ. Prone positioning was associated with more airway plugging or obstruction (rate ratio 4.83, 95% CI 1.38–16.82) and more stage 2 or worse pressure injuries (6% vs 1%). HFOV brought more haemodynamic instability (rate ratio 1.84).

In adults, prone positioning in severe ARDS has outcome evidence; this trial shows that benefit should not be assumed in children. For early paediatric ARDS, lung-protective conventional ventilation in the supine position remains the starting point.

• Do not use prone positioning or HFOV as routine first-line strategies in early paediatric ARDS
• Start with lung-protective conventional ventilation in the supine position
• If prone positioning is used as rescue, watch closely for tube obstruction and pressure injury
• Expect more haemodynamic instability on HFOV
• Adult prone-positioning evidence does not transfer automatically to children

Why it matters

It stops an adult intervention being reflexively applied to children.

Don't overread it

The trial stopped early and was unblinded; it addresses first-line use in early ARDS, not rescue use in refractory hypoxaemia.

The statistics, in plain English

The Hodges–Lehmann shift of 0.0 days (95% CI −0.8 to 1.0) for prone positioning means the trial can rule out a benefit of more than about a day of ventilator-free time.

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