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

Long 1991.

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: 84% 
 Blinding of outcome measurement: Yes 
 Stratification: By birthweight and gender 
 Long‐term follow‐up: Sauve 1995, Courtney 1995
Participants Neonates 
 Birthweight equal to or >1250 grams (Canada) 
 Birthweight > 1350 grams (USA) 
 Respiratory distress syndrome 
 Assisted ventilation 
 a/A ratio <0.22 
 No proven lung maturity 
 No major congential anomaly 
 No evidence of hydrops fetalis 
 Age <24 hours 
 Infants Randomized: 
 Exosurf = 614 
 Control = 623
Interventions Intratracheal Exosurf Neonatal 
 (5 mg/kg) or sham treatment (air) 
 Second dose 12 hours later if infant remained on assisted ventilation
Outcomes PRIMARY OUTCOME: 
 Neonatal death or survival with bronchopulmonary dysplasia
SECONDARY OUTCOME 
 cardiorespiratory support 
 complications of Prematurity
Notes Primary outcome (mortality and bronchopulmonary dysplasia) reported based on intention to treat.
Other complications of prematurity reported based on treatment received.