| Methods |
Masking of randomisation: Yes
Masking of intervention: Yes
Masking of outcome assessment: No
Complete follow up: Yes for short term |
| Participants |
89 ventilated preterm neonates between 600‐1250 grams Bw were randomised to 4 groups:
Group 1: 24 neonates: mean (SD) GA 26.3 (1.6) wk and mean (SD) Bw 919.4 (142.0) grams
Group 2: 21 neonates: mean (SD) GA 25.1 (1.8) wk and mean (SD) Bw 863.3 (146.9) grams
Group 3: 21 neonates: mean (SD) GA 26.6 (1.9) wk and mean (SD) Bw 881.6 (184.2) grams
Group 4: 23 neonates: mean (SD) GA 26.3 (1.7) wk and mean (SD) Bw 884.7 (156.4) grams |
| Interventions |
Group 1: Received placebo on days 1, 4, 7, 14
Group 2: received a1PI at 60 mg/kg/dose on days 1, 4, 7, 14
Group 3: received a1PI at 120mg/kg/dose on days 1, 4, 7, 14
Group 4: received a1PI at 60 mg/kg/dose on days 1, 2, 3, 4, 7, 14 |
| Outcomes |
Oxygen dependency at 28 days amongst survivors
Oxygen dependency at 36 weeks PMA amongst survivors |
| 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 |
High risk |
Masking of intervention: Yes
Masking of outcome assessment: No |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete follow up: Yes for short term |
