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. 2001 Jul 23;2001(3):CD002775. doi: 10.1002/14651858.CD002775

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