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

Stevenson 1992.

Methods Randomized 
 Multicenter 
 Blinding of randomization: Yes (sealed envelopes) 
 Blinding of intervention: Attempted (treatment administered by a separate dosing team in a screened area) 
 Complete follow‐up: yes 
 Blinding of outcome measurement: yes 
 Stratification by Birthweight: (500 to 599 g, 600 to 699 g) and gender 
 Long‐term follow‐up: 
 Corbet (1995), Walther (1995): 83% of survivors evaluated
Participants Premature infants 
 Inborn 
 Birthweight 500‐699 grams 
 No proven lung maturity 
 No major congenital malformation 
 No fetal growth retardation 
 No evidence of hydrops fetalis 
 No purulent amnionitis 
 No maternal heroin addiction 
 Infants randomized: 
 Exosurf = 109 
 Air Placebo = 106
Interventions Intratracheal Exosurf Neonatal (5ml/kg) or sham treatment (air) in delivery room shortly after birth
Outcomes PRIMARY OUTCOME: 
 Neonatal mortality
SECONDARY OUTCOMES: 
 Ventilatory requirements 
 Death due to RDS 
 Bronchopulmonary dysplasia 
 Complications of prematurity
FOLLOW‐UP: 
 Assessed at 1 year adjusted age
Notes Primary analysis reported as intention to treat (BPD, mortality), other outcomes reported based on treatment administered
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk Stratification by Birthweight: (500 to 599 g, 600 to 699 g) and gender
Allocation concealment? Low risk Blinding of randomization: Yes (sealed envelopes)
Blinding? 
 All outcomes Low risk Blinding of intervention: Attempted (treatment administered by a separate dosing team in a screened area) 
 
 Blinding of outcome measurement: yes
Incomplete outcome data addressed? 
 All outcomes Low risk Complete follow‐up: yes
Long‐term follow‐up: 
 Corbet (1995), Walther (1995): 83% of survivors evaluated
Free of selective reporting? Low risk  
Free of other bias? Low risk