Inhaled Nitric Oxide (INO) In Hypoxic Respiratory Failure
This Phase 3, Double-blind, Randomized, Placebo controlled, multicenter study is to confirm the efficacy of inhaled nitric oxide for the management of hypoxic respiratory failure associated with pulmonary hypertension in preterm infants.
Study subjects will be administered either inhaled nitric oxide or placebo to determine if there is a change in oxygenation.
Hypoxic Respiratory Failure With Pulmonary Hypertension
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 For The Treatment Of Hypoxic Respiratory Failure With Pulmonary Hypertension In Preterm Infants|
- Arterial Blood Gases [ Time Frame: Day 1 through Day 6 ] [ Designated as safety issue: No ]
- Methemoglobin levels [ Time Frame: Treatment Duration ] [ Designated as safety issue: Yes ]
- Vital Signs [ Time Frame: Study Duration ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]
- cGMP Levels [ Time Frame: Day 1 through 14 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||October 2011 (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 through an INOvent delivery system for up to 14 days.
Other Name: INOmax
Placebo Comparator: Nitrogen
Nitrogen gas will be administered in the same manor as the experimental drug
This trial will be a multi-center, double blind, placebo-controlled, randomized clinical trial. All mothers identified with prolonged rupture of membranes and/or oligohydramnios, and all inborn infants < 30 weeks GA at birth will be screened for enrollment. Infants who meet all inclusion and exclusion criteria within the first 48 hours after birth will be randomized to either inhaled NO starting at 20 ppm, or matched placebo, delivered by means of a blinded INOvent® delivery device. Randomization will be stratified by center and treatment will be assigned using an interactive voice or web-based response system (IVRS). All infants will receive up to 14 days of therapy, following a dose reduction schedule. The primary outcome measure will be change in oxygenation at 1 hour after start of therapy. In order to determine the effects of iNO therapy on survival and need for mechanical ventilation, cross-over will not be allowed.
This clinical trial will attempt to demonstrate if pre-term infants may benefit from treatment with nitric oxide for inhalation. A multi-center study is necessary to recruit an appropriate number of subjects, and to reflect the variability of standard practice across the different participating centers. All treatment assignments are blinded in order to minimize the risk of bias in treatment and data collection. In addition, a concurrent placebo group has been chosen as the most appropriate control group since there may be temporal, institutional and national variations in average outcomes. Methemoglobin levels will be measured locally and will collected in a blinded manner.