The Science Journal of the American Association for Respiratory Care
Background: The purpose of our study was to determine if nitric oxide reduced the use of extracorporeal membrane oxygenation (ECMO) in neonates with severe pulmonary hypertension. We conducted a blinded, multi-center, randomized, controlled trial that compared placebo (nitrogen, FI02 = 0.98) to low dose inhaled nitric oxide (maximum dose of 20ppm, FI02 = 0.98)
Method: Neonates born after 34 weeks of gestation, who were 4 days old or less, required assisted ventilation and had an oxygen index of
Results: Baseline clinical characteristics were similar in the 122 patients in the placebo group and the 126 in the nitric oxide group. ECMO was used in 64% of the patients assigned to control and in only 38% of patients treated with inhaled nitric oxide (P=0.001). Mortality during the first 30 days of life was statistically the same in both groups (8 vs. 7% placebo vs. nitric oxide). Oxygenation, as assessed by changes in arterial to alveolar oxygenation ratio, improved more rapidly over time in patients treated with nitric oxide. There were no differences in the occurrence of intracranial hemorrhage, seizures requiring treatment, duration of mechanical ventilation or length of stay between the two groups. Neonates treated with inhaled nitric oxide developed chronic lung disease less often than neonates assigned to placebo (20 vs. 7%, p=0.02, placebo vs. nitric oxide).
Conclusions: Inhaled nitric oxide safely reduced the use of ECMO in near-term to term neonates with severe pulmonary hypertension.