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

McMillan 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: 93% 
 Blinding of outcome measurement: Yes 
 Stratification: Based on birthweight and gender. 
 Longterm Follow‐up: Saigal 1995, Courtney 1995
Participants Neonates 
 Birthweight 750‐1249 grams 
 Respiratory distress syndrome 
 Assisted ventilation 
 a/A ratio <0.22 
 Age 2‐24 hours 
 Infants Randomized: 
 Exosurf Neonatal = 176 
 Control = 168
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: 
 Survival without bronchopulmonary dysplasia at 28 days
SECONDARY OUTCOME 
 cardiorespiratory support 
 complications of prematurity
Notes Primary outcomes (survival without BPD), BPD and neonatal mortality reported based on intention to treat.
Other complications of prematurity reported based on treatment received.