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. 1998 Jul 27;1998(3):CD001149. doi: 10.1002/14651858.CD001149

Smyth 1995.

Methods Randomized 
 Multicenter 
 Blinding of randomization: Yes (opaque, sealed envelopes) 
 Blinding of intervention: Yes (drug administration team) 
 Complete Follow‐up: 
 Short term: Yes 
 Long term: 96% 
 Blinding of outcome measurement: Yes 
 Stratification: Based on birthweight and gender 
 Long‐term follow up: Casiro 1995, Courtney 1995
Participants Neonates 
 Birthweight 500‐749 grams 
 Respiratory distress syndrome 
 Assisted ventilation 
 a/A ratio <0.22 
 Age 2‐24 hours 
 Infants randomized: 
 Exosurf Neonatal = 115 
 Control = 109
Interventions Intratracheal Exosurf Neonatal 
 (5 ml/kg) or sham treatment (air) 
 Second dose 12 hours later if infant remained on assisted ventilation
Outcomes PRIMARY OUTCOME: 
 Neonatal mortality 
 bronchopulmonary dysplasia 
 survival at 28 days without BPD
SECONDARY OUTCOMES 
 cardiorespiratory support 
 complications of prematurity
Notes Primary outcome (neonatal mortality, BPD, survival without BPD) reported based on intention to treat.
Other complications of prematurity reported based on treatment received.