Paediatric anaesthesia & critical care
Endotracheal surfactant for infants with life-threatening bronchiolitis (BESS): a randomised, blinded, sham-controlled, phase 2 trial
Authors' conclusion
Poractant alfa, administered endotracheally to infants with early critical bronchiolitis, although safe, did not reduce the duration of IMV compared with the sham intervention.
Study context
- Population
- Preterm and term-born infants <26 weeks gestationally corrected age with bronchiolitis requiring invasive mechanical ventilation, 15 paediatric ICUs in the National Health Service (NHS) of England, Scotland and Northern Irelandrandomly assigned
- Participants
- 232 participants
- Comparison
- Endotracheal poractant alfa vs sham intervention
- Endotracheal poractant alfan = 115
- Sham interventionn = 117reference
- Primary endpoint
- Duration of IMV from randomisation to final successful extubation
Methodological detailsmulticentre, blinded, sham-controlled, parallel-group, phase 2, superiority, Three infants withdrawn; none lost to follow-up, Randomisation stratified by duration of invasive mechanical ventilation (IMV) before randomisation (<24 h and ≥24 h) and by site
- Multicentre
- Blinded
- Sham-controlled
- Parallel-group
- Phase 2
- Superiority
- Three infants withdrawn; none lost to follow-up
- Randomisation stratified by duration of IMV before randomisation (<24 h and ≥24 h) and by site
Primary result
As reported in the abstract
Further findings
- Deaths
- 0
- No clinically significant safety issues associated with endotracheal poractant alfa
- Analysed in infants who received at least one trial intervention
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Endotracheal surfactant for infants with life-threatening bronchiolitis (BESS): a randomised, blinded, sham-controlled, phase 2 trial. Lancet Respir Med. Published 21 March 2026. doi:10.
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