Stiskal 1998.
Methods | Masking of randomisation: Yes Masking of intervention: Yes Masking of outcome assessment: Yes Complete follow up: No | |
Participants | Total of 106 patients enrolled. Bw 600‐1000 requiring intubation and 1001‐1250 grams with respiratory distress syndrome were eligible for inclusion in the study Group 1: 53 neonates with mean (SD) GA 26.1 (1.7) wk and mean (SD) Bw 861 (167) grams and Group 2: 53 neonates with mean (SD) GA 26.5 (1.7) wk and mean Bw 864 (175) grams | |
Interventions | Group 1; received 60 mg/kg/dose of a1PI over 5 minutes within first 24 hours of age and this dose was repeated on days 4, 7, 14 at standard times. Group 2: received equivalent volume of placebo (Human Albumin 5%) at the same times. | |
Outcomes | Incidence of CLD (oxygen dependency at 28 days) in survivors Incidence of CLD (oxygen dependency at 36 weeks PMA) Death or oxygen dependence at 36 weeks PMA Need for systemic steroid administration Age at final extubation Age off all respiratory support Duration of oxygen requirement Death before discharge | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | Masking of randomisation: Yes |
Blinding (performance bias and detection bias) All outcomes | Low risk | Masking of intervention: Yes Masking of outcome assessment: Yes |
Incomplete outcome data (attrition bias) All outcomes | High risk | Complete follow up: No |
GA = Gestational age CLD = Chronic lung disease Bw = Birth weight a1PI = alpha 1 proteinase inhibitor SD = standard deviation wk = weeks