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. 2010 Jan 20;2010(1):CD001079. doi: 10.1002/14651858.CD001079.pub2

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
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