Subhedar 1997.
Methods | Single‐centre randomised comparison of iNO, dexamethasone, combined therapy and control, using a 2 × 2 factorial design | |
Participants | 42 preterm infants less than 32 weeks' gestation with "high risk" of developing BPD | |
Interventions | iNO initially administered at 20 ppm and weaned if effective (n = 20) or control (n = 22). Dexamethasone at 1 mg/kg/d for 3 days, followed by 0.5 mg/kg/d for 3 days (n = 21) (3 infants received a lower dose), or no steroids (n = 21) | |
Outcomes | Primary outcome was survival without bronchopulmonary dysplasia. Secondary outcomes included duration of ventilation, intraventricular haemorrhage and other neonatal complications. | |
Notes | Initially planned 88 participants | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
Allocation concealment (selection bias) | Low risk | Masking of allocation: yes |
Blinding (performance bias and detection bias) All outcomes | High risk | Masking of intervention: no Masking of outcome measurement: no |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Completeness of follow‐up: yes |
Selective reporting (reporting bias) | Unclear risk | No registration or protocol found |
Other bias | High risk | Terminated early because frequency of adverse primary outcome was close to 100% in all groups |
Funding Source | Low risk | Government agency and local funds, some support from industry |