• Death
  
• Chronic Lung Disease at 36 weeks
  

This multicenter, randomized, double-masked, controlled clinical trial evaluates the efficacy of inhaled nitric oxide (iNO) in the treatment of the preterm infant with respiratory failure secondary to respiratory distress syndrome (RDS), sepsis/pneumonia, aspiration syndrome, idiopathic pulmonary hypertension and/or suspected pulmonary hypoplasia. Infants are followed until death or discharge to home. The trial compares iNO therapy to mock gas delivery as the control and otherwise incorporates conventional management strategies (including treatment with surfactant and high frequency ventilation as adjuncts to iNO therapy). During the initial dosing, iNO is started at 5 ppm and may be increased to 10 ppm. If the infant does not respond, study gas is discontinued. For infants who respond to study gas, a gradual weaning is initiated following a well-defined protocol. The total exposure to study gas may not exceed 336 hours (14 days). Infants are monitored for signs of toxicity. Medical and neurodevelopmental outcome of surviving infants will be assessed at 18 to 22 months corrected age by masked, certified examiners.

To demonstrate that the use of iNO is associated with a clinically significant reduction (from 75% to 60%) in the primary outcome variable (incidence of death or BPD during initial hospitalization) using a power of 0.90 and an alpha of 0.05 for a two-tailed test, a sample of 440 will be required (220 infants in each arm of the study).