Dataset from Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure

This was a multicenter, randomized, blinded, controlled trial to determine whether inhaled nitric oxide (iNO) reduced the rate of death or bronchopulmonary dysplasia (BPD) in infants. The study included 420 neonates, born at less than 34 weeks of gestation, with a birth weight of 401-1500 grams, and with respiratory failure more than 4 hours after treatment with surfactant to receive placebo (simulated flow) or iNO (5 to 10 ppm). Infants with a response (an increase in the partial pressure of arterial oxygen of more than 10 mm Hg) were weaned. The rate of death or BPD was 80% in the iNO group, as compared with 82% in the placebo group, and the rate of BPD was 60% versus 68%. In conclusion, use of iNO in critically ill premature infants weighing less than 1500 grams does not decrease the rates of death or BPD. Outcomes of surviving infants were assessed at 18 to 22 months corrected age; iNO did not reduce death or neurodevelopmental impairment or improve neurodevelopmental outcomes.