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. |