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 |
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Notes | Primary outcome (mortality and bronchopulmonary dysplasia) reported based on intention to treat. Other complications of prematurity reported based on treatment received. |