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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants Requiring Mechanical Ventilation or Positive Pressure Support on Days

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 Summary: 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.
Sponsor: Mallinckrodt

Current Primary Outcome: Survival Without BPD at 36 Weeks [ Time Frame: Baseline, 36 weeks PMA ]

Original Primary Outcome: Arterial Blood Gases [ Time Frame: Baseline, 36 weeks PMA, at discharge ]

Current Secondary Outcome: Days of Airway Pressure Support - Intent-to-treat Population [ Time Frame: during birth hospitalization ]

Airway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.


Original Secondary Outcome:

  • Vital Signs [ Time Frame: Baseline, 1 hour, day 1, weeks 36, 40, 44 PMA, at discharge ]
  • Methemoglobin levels [ Time Frame: Baseline, days 1 through 3 ]
  • cGMP levels [ Time Frame: Baseline, days 3 through 24, 36 weeks PMA ]
  • Adverse Events [ Time Frame: Treatment duration ]
  • Serious Adverse Events [ Time Frame: Study duration ]


Information By: Mallinckrodt

Dates:
Date Received: July 1, 2009
Date Started: November 2009
Date Completion:
Last Updated: September 8, 2016
Last Verified: September 2016