At a glance
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Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants Requiring Mechanical Ventilation or Positive Pressure Support on Days 5-14 After Birth
In Brief
A Phase 3 clinical trial evaluating Inhaled Nitric Oxide and Placebo for Bronchopulmonary Dysplasia. Completed, enrolled 451 participants across 33 sites in 2 countries.
Detailed Summary
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.
Study Details
Timeline
Interventions
Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
Nitrogen gas will be administered in the same manner as the experimental drug.