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Study stopped due to poor enrollment
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The purpose of this study is to determine the effect of nitric oxide for inhalation on the duration of mechanical ventilation in pediatric patients with AHRF.
Patients will receive 5-ppm study gas (nitric oxide for inhalation or placebo) until Day 28 or extubation, whichever comes first. The following will be performed / recorded at specified times during the study: arterial blood gases, ventilator settings, methemoglobin, PRISM III score, and patient positioning. Selected centers will also be performing plasma cytokine assays, broncho-alveolar lavage fluid assays and a 6 month follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | Nitrogen gas |
|
| 1 | Experimental | Inhaled Nitric Oxide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrogen gas | Drug | Nitrogen gas will be given at 5ppm until Day 28 or extubation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| arterial blood gases | baseline through 24 hours and extubation |
| Measure | Description | Time Frame |
|---|---|---|
| methemoglobin | baseline, hour 4 and 24 hours | |
| broncho-alveolar lavage fluid | baseline, 48 hours and day 5 | |
| Prone position |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Baldassarre, MD | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chrildren's Hospital of Orange County | Orange | California | 92868 | United States | ||
| Stanford University Medical Center |
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| inhaled nitric oxide |
| Drug |
inhaled nitric oxide will be given at 5 ppm until day 28 or extubation |
|
|
| baseline then daily |
| Stanford |
| California |
| 94305 |
| United States |
| The Children's Hospital | Denver | Colorado | 80218 | United States |
| Nemours Children's Clinic | Orlando | Florida | 32806 | United States |
| Children's Healthcare of Atlanta at Egleston | Atlanta | Georgia | 30322 | United States |
| University of Chicago, Children's Hospital | Chicago | Illinois | 60637 | United States |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana | 71103 | United States |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| New York Presbyterian Hospital | New York | New York | 10021 | United States |
| Children's Hospital at Montefiore | The Bronx | New York | 10467 | United States |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Children's Hospital | Columbus | Ohio | 43205 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| The Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Virginia Pediatric Critical Care | Charlottesville | Virginia | 22908 | United States |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009584 | Nitrogen |
| D045462 | Endothelium-Dependent Relaxing Factors |
| ID | Term |
|---|---|
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D014665 | Vasodilator Agents |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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