Yoder 2013.
Methods | Multi‐centre parallel‐group randomised trial | |
Participants | 451 preterm infants, < 1250 grams and < 30 weeks, at 5 to 14 days of age, on invasive ventilation, or on non‐invasive support if they weighed < 800 grams | |
Interventions | iNO at 20 ppm for 3 to 4 days, then 10 ppm for 10 days, then 5 ppm until 24 days | |
Outcomes | Survival without BPD, duration of respiratory support and hospitalisation | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Centralised computer‐generated |
Allocation concealment (selection bias) | Low risk | Placebo‐controlled trial |
Blinding (performance bias and detection bias) All outcomes | Low risk | Masked trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No significant attrition |
Selective reporting (reporting bias) | Low risk | Registered trial, primary outcomes reported |
Other bias | Low risk | |
Funding Source | High risk | Industry initiated and funded (Ikaria) |
a/AO2: arterial‐alveolar oxygen ratio. BPD: bronchopulmonary dysplasia. CMV: cytomegalovirus. CPAP: continuous positive airway pressure. FiO2: fraction of inspired oxygen. HVOF: high‐velocity oxygen fuel. iNO: inhaled nitric oxide. IVH: intraventricular haemorrhage. MRC: Medical Research Council. NEC: necrotising enterocolitis. NICHD: Eunice Kennedy Shriver National Institute of Child Health and Human Development. NO: nitric oxide. PDA: patent ductus arteriosus. PVL: periventricular leukomalacia. RDS: respiratory distress syndrome. ROP: retinopathy of prematurity.