CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 124 enrolled
Drug / intervention
Inhaled Nitric Oxide (iNO) +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.

Search/NCT00955487
NCT00955487Phase 2Completed

Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns

University of Colorado, Denver·interventional·Posted Aug 10, 2009·Updated Jun 15, 2017

In Brief

A Phase 2 clinical trial evaluating Inhaled Nitric Oxide (iNO) and Nitrogen (placebo) for Bronchopulmonary Dysplasia. Completed, enrolled 124 participants across 6 sites.

Detailed Summary

Bronchopulmonary dysplasia (BPD) is a serious lung condition that affects premature newborns. The condition involves abnormal development of lung tissue and is characterized by inflammation and scarring in the lungs. Treatment with inhaled nitric oxide (iNO) may reduce the incidence of BPD and another commonly associated condition called pulmonary hypertension, which is high blood pressure in the vessels carrying blood to the lungs.. This study will determine if early treatment with low-dose iNO reduces the incidence of BPD, pulmonary hypertension, and death in premature newborns.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 10, 2009
Enrollment StartJan 1, 2007
Primary CompletionJul 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 16.9 years ago

Interventions

Inhaled Nitric Oxide (iNO)drug

iNO will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).

Nitrogen (placebo)drug

Nitrogen will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).