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 |