Stevenson 1992.
Methods | Randomized Multicenter Blinding of randomization: Yes (sealed envelopes) Blinding of intervention: Attempted (treatment administered by a separate dosing team in a screened area) Complete follow‐up: yes Blinding of outcome measurement: yes Stratification by Birthweight: (500 to 599 g, 600 to 699 g) and gender Long‐term follow‐up: Corbet (1995), Walther (1995): 83% of survivors evaluated | |
Participants | Premature infants Inborn Birthweight 500‐699 grams No proven lung maturity No major congenital malformation No fetal growth retardation No evidence of hydrops fetalis No purulent amnionitis No maternal heroin addiction Infants randomized: Exosurf = 109 Air Placebo = 106 | |
Interventions | Intratracheal Exosurf Neonatal (5ml/kg) or sham treatment (air) in delivery room shortly after birth | |
Outcomes | PRIMARY OUTCOME:
Neonatal mortality SECONDARY OUTCOMES: Ventilatory requirements Death due to RDS Bronchopulmonary dysplasia Complications of prematurity FOLLOW‐UP: Assessed at 1 year adjusted age |
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Notes | Primary analysis reported as intention to treat (BPD, mortality), other outcomes reported based on treatment administered | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Stratification by Birthweight: (500 to 599 g, 600 to 699 g) and gender |
Allocation concealment? | Low risk | Blinding of randomization: Yes (sealed envelopes) |
Blinding? All outcomes | Low risk | Blinding of intervention: Attempted (treatment administered by a separate dosing team in a screened area) Blinding of outcome measurement: yes |
Incomplete outcome data addressed? All outcomes | Low risk | Complete follow‐up: yes Long‐term follow‐up: Corbet (1995), Walther (1995): 83% of survivors evaluated |
Free of selective reporting? | Low risk | |
Free of other bias? | Low risk |