| Methods |
Randomized multicenter trial
Blinding of randomization: yes
Blinding of intervention: yes
Complete follow‐up: no (25 excluded)
Blinding of outcome measurement: yes |
| Participants |
Gestational age less than or equal to 29 weeks
Intubated and stabilized by 15 minutes of age
No life‐threatening congenital anomaly
colfosceril palmitate (Exosurf Neonatal) n=423
Infasurf n=423 |
| Interventions |
Infasurf vs. colfosceril palmitate (Exosurf Neonatal)
Multiple doses
Crossover treatment allowed for persistent respiratory insufficiency |
| Outcomes |
PRIMARY:
Incidence of RDS
Incidence of death due to RDS
Survival without BPD at 28 days
SECONDARY:
Clinical Improvement
Complications of prematurity
Mortality |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
Blinding of randomization: yes |
| 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 (25 excluded) |
| Selective reporting (reporting bias) |
Low risk |
|
