Ikaria Inc, Hampton, NJ, has completed patient enrollment for its phase III trial investigating the use of inhaled nitric oxide (iNO) in premature infants with bronchopulmonary dysplasia (BPD). The enrollment of this last patient puts the trial 6 weeks ahead of schedule. The trial design includes a 1-year follow-up assessment, as discussed with the US Food and Drug Administration (FDA).
This multicenter, double blind, placebo-controlled, randomized clinical trial, entitled, Inhaled Nitric Oxide for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants, or the "NewNO Trial," aims to determine whether preterm infants who require mechanical ventilation or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO. In eligible subjects, iNO was administered continuously at a starting dose of 20 ppm for a duration of 24 days.
Inhaled nitric oxide selectively relaxes the cells of the pulmonary vasculature, resulting in increased blood flow through the lungs and delivery of more oxygenated blood to the body. Inhaled nitric oxide may also have beneficial effects on the development of pulmonary blood vessels and airspaces.
Inhaled nitric oxide is available as INOMAX® (nitric oxide) for inhalation, a vasodilator, which, in conjunction with ventilation and other appropriate agents, treats term and near-term newborns (>34 weeks gestation) with hypoxic respiratory failure associated with evidence of pulmonary hypertension. INOMAX is not approved for use in BPD.
Source: Ikaria Inc
