Hypoxic Respiratory Failure With Pulmonary Hypertension Clinical Trial
Official title:
Inhaled Nitric Oxide For The Treatment Of Hypoxic Respiratory Failure With Pulmonary Hypertension In Preterm Infants
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.
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 gestational age (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.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment