| Methods |
Multi‐centre trial |
| Participants |
29 infants at less than 34 weeks' gestation with birth weight > 1500 grams; ventilated with OI > 15 on 2 consecutive blood gases between 30 minutes and 12 hours apart |
| Interventions |
iNO initially at 5 ppm to 10 ppm (210) or placebo (210) (if no response at 10 ppm, study gas was stopped). Weaning ≥ 10 hours after initiation. Maximum duration was 14 days. |
| Outcomes |
Primary outcome was reduced death or BPD at 36 weeks. Secondary outcomes were grade 3 or 4 intraventricular haemorrhage or periventricular leukomalacia, number of days of assisted ventilation and oxygen use, length of hospitalisation and threshold retinopathy of prematurity. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Central telephone randomisation, stratified and blocked |
| Allocation concealment (selection bias) |
Low risk |
Masked allocation |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Placebo‐controlled trial |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete follow‐up |
| Selective reporting (reporting bias) |
Low risk |
No evidence |
| Funding Source |
Low risk |
Government agency (NICHHD), partial support from industry (Ikaria) |
