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

Curley, MAQ; Kneyber, MCJ; Cheifetz, IM; Kong, M; Mahapatra, S; Schwarz, AJ; Phumeetham, S; Irby, K; Napolitano, N; Dawkins-Henry, OS; Birch, EE; Elliott, CF; Berry, LR; Downes, KJ; Natarajan, A; Detry, MA; Viele, K; Graves, TL; Matthay, M; Asaro, LA; Wypij, D; PROSpect Study Investigators; Paediatric Acute Lung Injury and Sepsis Investigators Network

doi:10.1016/s0140-6736(26)01949-5

Pediatric anesthesia & critical care

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

LancetPublished 31 Oct 2026international, two-by-two factorial, response-adaptive, phase 3, randomised controlled trial

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Authors' conclusion

We found no evidence to support prone positioning or HFOV as first-line strategies to improve ventilator-free days in patients with early, moderate-to-severe PARDS. Thus, the routine use of these strategies in this population is not recommended.

Study context

Population: Patients aged 2 weeks to 20 years, intubated and mechanically ventilated for less than 96 h before meeting criteria for moderate-to-severe PARDS, in 75 paediatric intensive care units in 18 countriesrecruited of 600 planned, 1045 patients were eligible
Participants: 424 patients

Comparison: Prone positioning with supine positioning and high-frequency oscillatory ventilation (HFOV) with conventional mechanical ventilation
Supine and conventional mechanical ventilationn = 126
Prone and conventional mechanical ventilationn = 130
Supine and HFOVn = 90
Prone and HFOVn = 78
Primary endpoint: Ventilator-free days
Follow-up: Through to day 28

Methodological detailsweb-based central randomisation, stratified by age group and direct or indirect lung injury, permuted block design, masking not possible

Web-based central randomisation
Stratified by age group and direct or indirect lung injury
Permuted block design
Masking not possible

Primary result

As reported in the abstract

Prone vs supine

Prone17.9median · IQR 8.9–21.3 · days

Supine17.4median · IQR 6.4–21.9 · days

Estimate (95% CI)

Hodges-Lehmann location shiftadjusting for ventilation

0.0(−0.8 to 1.0)

HFOV vs conventional mechanical ventilation

HFOV17.3median · IQR 5.7–21.6 · days

Conventional mechanical ventilation18.0median · IQR 9.9–21.5 · days

Estimate (95% CI)

Hodges-Lehmann location shiftadjusting for positioning

−0.3(−1.5 to 0.5)

Further findings

Death · day 28

Patients had died at day 28: 41 (10%)
Without group differences

Conduct of the study

The trial was stopped early for futility and slow enrolment after 424 of 600 planned patients were recruited.

Safety

Prone vs supine

Outcome	Prone	Supine	← Lower with prone ←→ Higher with prone →	Estimate
Plugging or obstruction of the artificial airwayEvents per 100 artificial airway days	0.74 (95% CI 0.44–1.26)	0.15 (95% CI 0.05–0.47)	0.050.21520	rate ratio 4.83 (95% CI 1.38–16.82)
Stage 2 or worse immobility-related pressure injuries	6%	1%	0.050.21520	relative risk 6.13 (95% CI 1.45–25.97)
			0.050.21520Ratio (log scale)

HFOV vs conventional mechanical ventilation

Outcome	HFOV	Conventional mechanical ventilation	← Lower with HFOV ←→ Higher with HFOV →	Rate ratio (95% CI)
Haemodynamic instabilityEvents per 100 paediatric intensive care unit days	2.21 (95% CI 1.63–3.00)	1.22 (95% CI 0.89–1.68)	0.20.5125	1.84 (1.18–2.87)
			0.20.5125Rate ratio (log scale)

Serious adverse event

Unwitnessed self-extubation followed by cardiopulmonary arrest, in a patient in the prone and conventional mechanical ventilation group: One

Original publication

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. Lancet. Published 31 October 2026. doi:10.1016/s0140-6736(26)01949-5

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