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

Bose 1990.

Methods Randomized 
 Multicenter 
 Blinding of randomization: yes 
 Blinding of intervention: Attempted (infants treated in screened area by special drug administration team who did not participate in subsequent care) 
 Complete follow‐up: yes 
 Blinding of outcome measurement: yes 
 Stratification by birthweight (700‐1000g, 1001‐1350g) and gender 
 Long‐term follow‐up: 
 Corbet (1995), Kraybill (1995) 80% of survivors evaluated
Participants Premature infants 
 Inborn 
 Birthweight 700‐1350 grams 
 No proven lung maturity 
 No fetal anomaly or chromosomal abnormality 
 No fetal growth retardation 
 No evidence of hydrops fetalis 
 No proven chorioamnionitis 
 No maternal heroin addiction 
 Infants randomized: 
 Exosurf = 192 
 Air Placebo = 193
Interventions Intubation and intratracheal administration of Exosurf Neonatal (5ml/kg) as soon after birth as possible or intubation and sham air treatment
Outcomes PRIMARY OUTCOME: 
 Survival at 28 days of age without bronchopulmonary dysplasia
SECONDARY OUTCOMES: 
 Ventilatory requirements 
 Respiratory distress syndrome 
 Complications of prematurity
FOLLOW‐UP: 
 Assessed at 1 and 2 years 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 by birthweight (700 to 1000 g, 1001 to 1350 g) and gender
Allocation concealment? Low risk Blinding of randomization: yes
Blinding? 
 All outcomes Low risk Blinding of intervention: Attempted (infants treated in screened area by special drug administration team who did not participate in subsequent care) 
 
 Blinding of outcome measurement: yes
Incomplete outcome data addressed? 
 All outcomes Low risk Complete follow‐up: yes
Long‐term follow‐up: 
 Corbet (1995), Kraybill (1995) 80% of survivors evaluated
Free of selective reporting? Low risk  
Free of other bias? Low risk