Ballard 2006.
Methods | Multi‐centre trial | |
Participants | 582 infants < 1250 grams on assisted ventilation at 7‐21 days (or, if < 800 grams, on CPAP) | |
Interventions | Inhaled NO at 20 ppm initial dose for 48‐96 hours; the dose was subsequently decreased to 10, 5 and 2 ppm at weekly intervals, with a minimum treatment duration of 24 days | |
Outcomes | Survival without BPD at 36 weeks' postmenstrual age Secondary outcomes included duration of oxygen therapy and duration of hospitalisation. In addition, investigators prospectively evaluated the need for hospitalisation and respiratory support, including mechanical ventilation, continuous positive airway pressure and oxygen supplementation at 40, 44, 52 and 60 weeks' postmenstrual age. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised in permuted blocks at study centre |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
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 | |
Other bias | Low risk | |
Funding Source | Low risk | Funded by a government agency (NICHD); study gas provided by industry (Ikaria) |