EUNO 2009.
Methods | Multi‐centre trial | |
Participants | 800 infants between 24 weeks' and 28 weeks' gestation and 6 days enrolled at less than 24 hours of age. If intubated, they had to have received surfactant and could be enrolled if on CPAP requiring > 30% oxygen. Patients were ineligible if they required more than 50% O2 to maintain saturation over 85% on a mean airway pressure ≥ 8 cmH2O. | |
Interventions | Inhaled NO at 5 ppm for at least 7 and a maximum of 21 days | |
Outcomes | Primary outcome was survival without BPD at 36 weeks' postmenstrual age. Secondary outcome was survival without severe brain injury on head ultrasonography. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated |
Allocation concealment (selection bias) | Low risk | Centralised interactive Web‐based enrolment and randomisation system |
Blinding (performance bias and detection bias) All outcomes | Low risk | Masking of intervention: yes Masking of outcome assessment: yes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Completeness of follow‐up: yes |
Selective reporting (reporting bias) | Low risk | Registered trial, primary outcomes reported |
Other bias | Low risk | |
Funding Source | High risk | Funded by industry (Ikaria), initiated by investigators |