Methods |
Randomized and historical controls (only randomized subjects included in this review), single center trial
Blinding of randomization: yes
Blinding of intervention: no
Complete follow‐up: yes
Blinding of outcome measurement: no |
Participants |
Birth weight 500‐1500 grams
Premature infants
Assisted ventilation
Respiratory distress syndrome
Age less than or equal to 8 hours
a/A ratio less than or equal to 0.22 or supplemental oxygen greater than or equal to 0.4
No evidence of life‐threatening congenital malformation
Randomized infants:
Colfosceril palmitate (Exosurf Neonatal) n= 61
Beractant (Survanta) n= 61 |
Interventions |
Beractant (Survanta) vs. colfosceril palmitate (Exosurf Neonatal)
Multiple doses |
Outcomes |
Average FiO2
Mean airway pressure
Duration of ventilation
Duration of supplemental oxygen
Mortality
Complications of prematurity |
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 |
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 |
Selective reporting (reporting bias) |
Low risk |
|