| Methods |
Randomized multicenter trial
Blinding of randomization: yes
(central telephone randomization using sealed envelopes)
Blinding of intervention: no
Complete follow‐up: no (excluded 13 randomized ineligible infants)
Blinding of outcome measurement: no
Stratification by referral center |
| Participants |
Gestational age 25‐30 weeks
Intubated for presumed surfactant deficiency
Clinical signs of RDS
No evidence of life‐threatening congenital malformation
Pumactant n= 100
Curosurf (poractant alfa) n= 99 |
| Interventions |
Curosurf (poractant alfa) vs. pumactant
Multiple doses |
| Outcomes |
PRIMARY:
Days spent in "high dependency care" (including assisted ventilation, NCPAP, supplemental oxygen greater than 40%, thoracostomy tube, weight less than 1000 grams)
SECONDARY:
Neonatal mortality
Complications of prematurity |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Central telephone randomization using sealed envelopes |
| 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 |
High risk |
Complete follow‐up: no (excluded 13 randomized ineligible infants) |
| Selective reporting (reporting bias) |
Low risk |
|
