At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 800 enrolled
Drug / intervention
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.
The Effects of Nitric Oxide for Inhalation on the Development of Chronic Lung Disease in Pre-term Infants
In Brief
A Phase 3 clinical trial evaluating Nitric oxide and Placebo for Lung Disease. Completed, enrolled 800 participants across 35 sites in 9 countries.
Detailed Summary
The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy on the development of these children over 7 years of clinical follow-up.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Disease
CountriesBelgium, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2005
First PostedOct 2007
Primary CompletionMar 2008
Study CompletionJul 2015
TodayJul 2026
First PostedOct 31, 2007
Enrollment StartMay 29, 2005
Primary CompletionMar 16, 2008
Study CompletionJul 17, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.7 years ago
Interventions
Nitric oxidedrug
Nitric Oxide vapour (gas) for inhalation (400 ppm)
Placebodrug
Placebo gas for inhalation