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| Sponsored by: |
INO Therapeutics |
| Information provided by: | INO Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00041561 |
Purpose
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.
| Condition | Intervention | Phase |
|
Respiratory Insufficiency Anoxemia |
Drug: Nitrogen gas Drug: inhaled nitric oxide |
Phase III |
| MedlinePlus related topics: | Children's Health |
| ChemIDplus related topics: | Nitric oxide |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | The Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) In Pediatrics |
| Enrollment: | 55 |
| Study Start Date: | January 2002 |
| Study Completion Date: | December 2004 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
2: Placebo Comparator
Nitrogen gas
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Drug: Nitrogen gas
Nitrogen gas will be given at 5ppm until Day 28 or extubation
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1: Experimental
Inhaled Nitric Oxide
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Drug: inhaled nitric oxide
inhaled nitric oxide will be given at 5 ppm until day 28 or extubation
|
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.
Eligibility
| Ages Eligible for Study: | up to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| United States, California | |||||
| Chrildren's Hospital of Orange County | |||||
| Orange, California, United States, 92868 | |||||
| Stanford University Medical Center | |||||
| Stanford, California, United States, 94305 | |||||
| United States, Colorado | |||||
| The Children's Hospital | |||||
| Denver, Colorado, United States, 80218 | |||||
| United States, Florida | |||||
| Nemours Children's Clinic | |||||
| Orlando, Florida, United States, 32806 | |||||
| United States, Georgia | |||||
| Children's Healthcare of Atlanta at Egleston | |||||
| Atlanta, Georgia, United States, 30322 | |||||
| United States, Illinois | |||||
| University of Chicago, Children's Hospital | |||||
| Chicago, Illinois, United States, 60637 | |||||
| United States, Louisiana | |||||
| Louisiana State University Health Sciences Center - Shreveport | |||||
| Shreveport, Louisiana, United States, 71103 | |||||
| United States, Maryland | |||||
| The Johns Hopkins Hospital | |||||
| Baltimore, Maryland, United States, 21287 | |||||
| United States, New York | |||||
| New York Presbyterian Hospital | |||||
| New York, New York, United States, 10021 | |||||
| Children's Hospital at Montefiore | |||||
| Bronx, New York, United States, 10467 | |||||
| United States, Ohio | |||||
| Children's Hospital Medical Center of Akron | |||||
| Akron, Ohio, United States, 44308 | |||||
| Children's Hospital | |||||
| Columbus, Ohio, United States, 43205 | |||||
| The Cleveland Clinic Foundation | |||||
| Cleveland, Ohio, United States, 44195 | |||||
| United States, Oregon | |||||
| Oregon Health and Science University | |||||
| Portland, Oregon, United States, 97239 | |||||
| United States, South Carolina | |||||
| The Medical University of South Carolina | |||||
| Charleston, South Carolina, United States, 29425 | |||||
| United States, Virginia | |||||
| University of Virginia Pediatric Critical Care | |||||
| Charlottesville, Virginia, United States, 22908 | |||||
| INO Therapeutics |
| Study Director: | James Baldassarre, MD | INO Therapeutics |
More Information
| Responsible Party: | INO Therapeutics ( James Baldassarre ) |
| Study ID Numbers: | INOT-11 |
| First Received: | July 10, 2002 |
| Last Updated: | February 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00041561 |
| Health Authority: | United States: Food and Drug Administration |
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