| Methods |
Randomized multicenter trial (3 centers)
Blinding of randomization: yes (sealed envelopes)
Blinding of intervention: no
Complete follow‐up: no (7 randomized infants excluded due to early mortality)
Blinding of outcome measurement: no
Stratification by birth weight, gender |
| Participants |
Newborn infants
Assisted ventilation
Respiratory distress syndrome
a/A ratio < 0.22
No major congenital anomaly
Colfosceril palmitate (Exosurf Neonatal) n=115
Curosurf n=113 |
| Interventions |
Curosurf vs. colfosceril palmitate (Exosurf Neonatal)
Multiple doses |
| Outcomes |
PRIMARY:
Duration of assisted ventilation
Duration of supplemental oxygen
SECONDARY:
Complications of prematurity |
| 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 |
High risk |
Blinding of intervention: no |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
|
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Blinding of outcome measurement: no |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Complete follow‐up: no
(7 randomized infants excluded due to early mortality) |
| Selective reporting (reporting bias) |
Low risk |
|
