NCT00931632

Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 451 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 5 Days – 14 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	Inhaled Nitric Oxide	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.
DRUG	Placebo	Nitrogen gas will be administered in the same manner as the experimental drug.

Timeline

• Start date: 2009-11-01
• Primary completion: 2013-05-01
• Completion: 2014-05-01
• First posted: 2009-07-02
• Last updated: 2017-12-04
• Results posted: 2015-08-11

Locations

33 sites across 2 countries: United States, Canada