Corbet 1991.
Methods | Randomized Multicenter study Blinding of randomization: yes (sealed envelopes) Blinding of intervention: yes (staff not involved in clinical care administered assigned treatment in screened area Complete follow‐up: yes Blinding of outcome measures: yes Stratification based on gestational age and gender Long‐term follow‐up: Corbet (1995), Sell (1995): 82% of survivors evaluated | |
Participants | Premature infants Birthweight 700 to 1100 grams No proven lung maturity No major congenital malformation No fetal growth retardation No evidence of hydrops fetalis No purulent amnionitis No maternal heroin addition Infants randomized: Exosurf = 224 Air Placebo = 222 | |
Interventions | Intratracheal Exosurf Neonatal (5ml/kg) or sham treatment (air) in delivery room within 30 minutes after birth | |
Outcomes | PRIMARY OUTCOME:
Survival at age 28 days without bronchopulmonary dysplasia SECONDARY OUTCOMES: Respiratory distress, mortality, complications of prematurity FOLLOW‐UP: Assessed at 1 year adjusted age |
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Notes | Evaluation of BPD, neonatal mortality does not include infants with congenital malformation or congenital pneumonia | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Stratification based on gestational age and gender |
Allocation concealment? | Low risk | Blinding of randomization: yes (sealed envelopes) |
Blinding? All outcomes | Low risk | Blinding of intervention: yes (staff not involved in clinical care administered assigned treatment in screened area Blinding of outcome measures: yes |
Incomplete outcome data addressed? All outcomes | Low risk | Complete follow‐up: yes Long‐term follow‐up: Corbet (1995), Sell (1995): 82% of survivors evaluated |
Free of selective reporting? | Low risk | |
Free of other bias? | Low risk |