At a glance
ClinicalIndex Comparison RecordPhase 3Terminated· 420 enrolled
Drug / intervention
Inhaled nitric oxide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
In Brief
A Phase 3 clinical trial evaluating Inhaled nitric oxide and Placebo for Infant, Newborn and 7 related conditions. Terminated early, enrolled 420 participants across 17 sites.
Signals
Trial was terminated early
Detailed Summary
This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Respiratory Distress Syndrome (RDS), Sepsis, Pneumonia, Hypertension, Pulmonary
CountriesUnited States
CollaboratorsNational Center for Research Resources (NCRR)
Timeline
Phase 3TerminatedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2001
First PostedMay 2001
Primary CompletionSep 2003
Study CompletionMay 2006
TodayJul 2026
First PostedMay 16, 2001
Enrollment StartJan 1, 2001
Primary CompletionSep 1, 2003
Study CompletionMay 1, 2006
TodayJul 1, 2026
Enrollment to primary: 2.7 yearsPosted 25.1 years ago
Interventions
Inhaled nitric oxidedrug
Started at 5 ppm and could be increased to 10 ppm
Placebodrug
Started at 5 ppm and could be increased to 10 ppm