Kinsella 1999.
| Methods | Multi‐centre trial | |
| Participants | 80 preterm infants (≤ 34 weeks) < 7 days of age, with a/AO2 < 0.1 on 2 blood gases after surfactant treatment | |
| Interventions | Inhaled NO at 5 ppm (n = 48) or no supplemental gas (n = 32) for 7 days, after which "trials off" were allowed. Maximum treatment duration was 14 days. | |
| Outcomes | Primary outcome was survival. Bronchopulmonary dysplasia, intraventricular haemorrhage and duration of ventilation were secondary outcomes. |
|
| Notes | Initially planned 210 participants | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Central stratified randomisation |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Masked intervention |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up |
| Selective reporting (reporting bias) | Unclear risk | No protocol or registration document found |
| Other bias | High risk | Study terminated early after planned first interim analysis, as little difference in outcomes was apparent |
| Funding Source | Low risk | Funded by government agency (NIH) and in part by industry (iNOtherapeutics) |