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. 2015 Aug 24;2015(8):CD000144. doi: 10.1002/14651858.CD000144.pub3

Hudak 1996.

Methods Randomized multicenter trial
 Blinding of randomization: yes
 (sealed envelopes)
 Blinding of intervention: yes
 Complete follow‐up: no (7 excluded)
 Blinding of outcome measurement: yes
 Stratification by birth weight
Participants Respiratory distress syndrome
 Assisted ventilation
 a/A ratio less than or equal to 0.22
 Age less than 72 hours
 No evidence of life‐threatening congenital malformation
Colfosceril palmitate (Exosurf Neonatal) n=508
 Infasurf n=525
Interventions Infasurf v. colfosceril palmitate (Exosurf Neonatal)
 Treatment crossover for persistent respiratory insufficiency allowed after second dose
Outcomes PRIMARY:
 Pulmonary airleak
 SECONDARY:
 Crossover treatment
 Severity of RDS
 Mortality
 Survival without chronic lung disease
 Complications of prematurity
 Days on assisted ventilation
 Days in oxygen
 Days in hospital
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk Blinding of randomization: yes (sealed envelopes)
Blinding (performance bias and detection bias) 
 All outcomes Low risk Blinding of intervention: yes
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk  
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Blinding of outcome measurement: yes
Incomplete outcome data (attrition bias) 
 All outcomes High risk Complete follow‐up: no (7 excluded)
Selective reporting (reporting bias) Low risk