| Methods |
Multi‐centre randomised trial. Masking of allocation: yes. Masking of intervention: yes. Completeness of follow‐up: yes. Masking of outcome: yes |
| Participants |
248 near‐term infants, ≥ 34 weeks, ≤ 4 days of age, with OI ≥ 25 |
| Interventions |
20 ppm iNO or nitrogen placebo. Inhaled NO gas weaned to 5 ppm after 24 hours for a maximum of 96 hours |
| Outcomes |
Death before discharge, need for ECMO, chronic lung disease, neurological injury |
| Notes |
No calculation of sample size for the trial is described. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Cards on which treatment assignments were written were randomly ordered (shuffled by hand 3 times) and placed in sequentially numbered opaque envelopes in blocks of 8. |
| Allocation concealment (selection bias) |
Low risk |
Adequate |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
|
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
|
| Selective reporting (reporting bias) |
Unclear risk |
No registered or published protocol found |
| Other bias |
Unclear risk |
Uncertain how sample size was determined |
| Funding Source(s) |
High risk |
Funded "in part" by INOtherapeutics; no other sources listed |
