Conditions: Bronchopulmonary Dysplasia
Keywords: Bronchopulmonary Dysplasia, BPD
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 451
Healthy volunteers: no

Brief 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.

Detailed description:
Multi-center, double blind, placebo-controlled, randomized clinical trial. Infants who meet all enrollment criteria at any point during days 5 to 14 after birth will be randomized to inhaled NO starting at 20 ppm, or matching placebo, by means of a blinded INOvent® delivery device. All infants will receive 24 days of therapy, following a dose reduction schedule. Infants who are extubated before 24 days will continue therapy via nasal continuous positive airway pressure (CPAP) or nasal cannula to complete 24 days' of therapy. The primary outcome measure will be survival without BPD at 36 weeks gestational age using a physiologic assessment of BPD.

Arms:
arm 1: Inhaled Nitric Oxide arm 2: Nitrogen Placebo

Interventions: intervention 1: Inhaled Nitric Oxide intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: Nitrogen gas will be administered in the same manner as the experimental drug.

Protocol document: