daCosta 1999.
| Methods | Randomized single center trial Blinding of randomization: yes (Sealed envelopes) Blinding of intervention: no Complete follow‐up: yes Blinding of outcome measurement: no Stratification: none stated | |
| Participants | Gestational age less than 37 weeks Birth weight greater than 999 grams Assisted ventilation Supplemental oxygen greater than or equal to 40% Mean airway pressure greater than or equal to 7.5 cm H2O Respiratory distress syndrome Age less than or equal to 8 hours No evidence of life‐threatening congenital malformation, sepsis, pulmonary hypoplasia, circulatory collapse, pneumothorax, IVH grade 3‐4 Colfosceril palmitate (Exosurf Neonatal) n= 43 Beractant (Survanta) n= 46 | |
| Interventions | Beractant (Survanta) vs. colfosceril palmitate (Exosurf Neonatal) Multiple doses | |
| Outcomes | PRIMARY: Oxygenation Index at 24 hours Death or chronic lung disease at 28 days SECONDARY: Ventilator requirement 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) Stratification: none stated |
| 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 | |