| Methods |
Randomized multicenter trial
Blinding of randomization: yes
(randomization lists at study center pharmacy)
Blinding of intervention: no
Complete follow‐up: no (3 excluded)
Blinding of outcome measurement: no
Stratification by birth weight |
| Participants |
Birth weight 501‐1500 grams
Assisted ventilation
Supplemental oxygen greater than or equal to 30%
Respiratory distress syndrome
Age less than or equal to 6 hours
No mature L/S ratio
No evidence of life‐threatening congenital malformation
Colfosceril palmitate (Exosurf Neonatal) n= 309
Beractant (Survanta) n= 308 |
| Interventions |
Beractant (Survanta) vs. colfosceril palmitate (Exosurf Neonatal)
Multiple doses |
| Outcomes |
PRIMARY:
Death or BPD at 28 days
Average FiO2, mean airway pressure
SECONDARY:
Complications of prematurity
Complications associated with dosing |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
Blinding of randomization: yes (randomization lists at study center pharmacy) |
| 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 |
Low risk |
Complete follow‐up: yes (3 excluded) |
| Selective reporting (reporting bias) |
Low risk |
|
