Bose 1990.
Methods | Randomized Multicenter Blinding of randomization: yes Blinding of intervention: Attempted (infants treated in screened area by special drug administration team who did not participate in subsequent care) Complete follow‐up: yes Blinding of outcome measurement: yes Stratification by birthweight (700‐1000g, 1001‐1350g) and gender Long‐term follow‐up: Corbet (1995), Kraybill (1995) 80% of survivors evaluated | |
Participants | Premature infants Inborn Birthweight 700‐1350 grams No proven lung maturity No fetal anomaly or chromosomal abnormality No fetal growth retardation No evidence of hydrops fetalis No proven chorioamnionitis No maternal heroin addiction Infants randomized: Exosurf = 192 Air Placebo = 193 | |
Interventions | Intubation and intratracheal administration of Exosurf Neonatal (5ml/kg) as soon after birth as possible or intubation and sham air treatment | |
Outcomes | PRIMARY OUTCOME:
Survival at 28 days of age without bronchopulmonary dysplasia SECONDARY OUTCOMES: Ventilatory requirements Respiratory distress syndrome Complications of prematurity FOLLOW‐UP: Assessed at 1 and 2 years adjusted age |
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Notes | Evaluation of BPD, neonatal mortality does not include infants with congenital malformation or congenital pneumonia | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Stratification by birthweight (700 to 1000 g, 1001 to 1350 g) and gender |
Allocation concealment? | Low risk | Blinding of randomization: yes |
Blinding? All outcomes | Low risk | Blinding of intervention: Attempted (infants treated in screened area by special drug administration team who did not participate in subsequent care) Blinding of outcome measurement: yes |
Incomplete outcome data addressed? All outcomes | Low risk | Complete follow‐up: yes Long‐term follow‐up: Corbet (1995), Kraybill (1995) 80% of survivors evaluated |
Free of selective reporting? | Low risk | |
Free of other bias? | Low risk |