Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
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.
Drug: Inhaled Nitric Oxide
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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 5-14 After Birth|
- Survival without BPD at 36 weeks [ Time Frame: Baseline, 36 weeks PMA ] [ Designated as safety issue: Yes ]
- Vital Signs [ Time Frame: Study duration ] [ Designated as safety issue: No ]
- Need for respiratory support [ Time Frame: Study duration up to discharge ] [ Designated as safety issue: No ]air pressure support, oxygen
- Adverse Events [ Time Frame: During study drug administration only ] [ Designated as safety issue: Yes ]AEs will include intracranial hemorrhage; patent ductus requiring intervention; necrotizing enterocolitis; intestinal perforations; airs leaks of any type; pulmonary hemorrhage, retinopathy of prematurity; sepsis
- Incidence of methemoglobinemia [ Time Frame: Baseline, 24, 48 and 72 hours ] [ Designated as safety issue: Yes ]Includes elevated nitrogen dioxide concentrations
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Inhaled Nitric Oxide
Inhaled Nitric Oxide
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.
Placebo Comparator: Placebo
Nitrogen gas will be administered in the same manner as the experimental drug.
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 GA using a physiologic assessment of BPD.
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|Study Director:||James Baldassarre, MD||INO Therapeutics|