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. 2004 Oct 18;2004(4):CD004477. doi: 10.1002/14651858.CD004477.pub2
Methods n = 40, 11 centres
Allocation concealment: central randomization
Baseline similarity: age, modified APACHE II, sepsis
Blinding: caregivers unblinded (no placebo)
Cointerventions: daily screening for ability to wean
Withdrawals: none
Losses to follow‐up: none
Participants Inclusions: Risk factor for ARDS; AECC definition of ARDS; duration of ARDS not more than 48 hours; PEEP of at least 5 cmH20; at least 48 hours of antimicrobial therapy if pneumonia present
Exclusions: Hemodynamic instability; severe hypoxaemia; lung cancer; AIDS
Interventions Intratracheal synthetic surfactant (Venticute, containing 1 mg recombinant surfactant protein C and 50 mg phospholipids per ml), 1 ml/kg up to 4 doses in 24 hours, or 0.5 mL/kg up to 4 doses in 24 hours, or standard therapy
Outcomes 28 day mortality (all surfactant doses versus control): RR 0.67 (95% CI 0.26 to 1.72)
Ventilator‐free days to day 28 [median (interquartile range)]: low dose: 4 (0 to 12); high dose 5 (0 to 18); control: 6 (0 to 15); differences reported to be non significant
Adverse events leading to discontinuation of therapy: none
Other safety data: treatment: 1/27 patients had an adverse event likely related to treatment (transient hypoxia and supraventricular tachycardia); no difference in incidence of serious adverse events
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate