Abstract

Objective To evaluate whether combined surfactant with inhaled nitric oxide (iNO) use will prevent newborns with hypoxemic respiratory failure (HRF) from developing an Oxygenation Index (OI) > 40. Methods 100 term newborns with acute HRF (OI >= 20) were randomized to: Surfactant+iNO: received iNO plus up to two doses of surfactant or iNO-Controls: received iNO+placebo. Main outcome was the development of severe HRF (OI > 40) despite iNO use. Results Baseline mean +/- SD OI was 37.4 +/- 14 for the Surfactant+iNO group and 38.2 +/- 16 for the controls. Infants receiving surfactant+iNO improved their oxygenation faster, resulting in lower OI at 24 h: 12.9 +/- 9 vs 18.7 +/- 11 of controls,p < 0.05; and a lower proportion developing OI > 40: 24%(12/50) vs 50%(25/50) of controls,p < 0.02. Fewer infants receiving surfactant+iNO presented the combined outcome of death or ECMO: 16%(8/50) compared to 36%(18/50) of controls,p < 0.05. Conclusions Early use of combined surfactant+iNO improves oxygenation preventing the progression to severe HRF. This may reduce mortality and ECMO need.