CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 52 enrolled
Drug / intervention
Nitric Oxide +1 moredrug
Likely dose
Inhaled nitric oxide 10 parts per million (ppm) for 4 hoursAI-extracted
Key inclusion· 1
  • ✓Mechanically ventilated in PICU with severe hypoxemia: PaO2/FiO2 ratio ≤100, FiO2 ≥0.60, PEEP ≥10, and Murray score ≥2.5
Key exclusion· 2
  • ✕Neonates (1 week to 28 days old)
  • ✕On extracorporeal membrane oxygenation (ECMO)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00240487
NCT00240487Phase 3Completed
CompareCT.gov

Nitric Oxide Administration for Acute Respiratory Distress Syndrome

Children's Hospital of Philadelphia·interventional·Posted Oct 18, 2005·Updated Apr 24, 2015

In Brief

A Phase 3 clinical trial evaluating Nitric Oxide and No Intervention for Acute Respiratory Distress Syndrome. Completed, enrolled 52 participants across 1 site.

Detailed Summary

This research project is an open-label, randomized study for the use of Nitric Oxide in pediatric patients with acute respiratory distress syndrome (ARDS). The study examines whether nitric oxide (NO) treatment impacts the the P:F ratio (arterial partial pressure of oxygen (PaO2) divided by fraction of inspired oxygen (FiO2) in patients with ARDS. The goal of the study is to evaluate whether the order of NO therapy will have any effect on response, and evaluate the characteristics of patients who respond to NO compared to those who do not.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Respiratory Distress Syndrome
CountriesUnited States
CollaboratorsMallinckrodt

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 18, 2005
Enrollment StartSep 1, 2000
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 20.7 years ago

Interventions

Nitric Oxidedrug

Subjects will receive inhaled Nitric Oxide at a dose of 10 parts per million (ppm) for a 4 hour study period. Blood gases will be collected once an hour.

No Interventionother

Subjects will receive no intervention (i.e., no nitric oxide treatment) for a 4 hour study period. Blood gases will be collected once an hour. During this time, all subjects will receive standard clinical care.