Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics
NCT ID: NCT00041561
Last Updated: 2016-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
55 participants
INTERVENTIONAL
2002-01-31
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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2
Nitrogen gas
Nitrogen gas
Nitrogen gas will be given at 5ppm until Day 28 or extubation
1
Inhaled Nitric Oxide
inhaled nitric oxide
inhaled nitric oxide will be given at 5 ppm until day 28 or extubation
Interventions
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Nitrogen gas
Nitrogen gas will be given at 5ppm until Day 28 or extubation
inhaled nitric oxide
inhaled nitric oxide will be given at 5 ppm until day 28 or extubation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 44 weeks post conceptional age to 16 years of age
* Oxygenation Index (OI) \>=12 cm H2O/mmHg (as determined by two separate measurement taken 30 minutes to 4 hours apart)
* Recent chest x-ray (within 24 hours) showing at least unilateral infiltrations
* Mechanically ventilated \<= 7 days
Exclusion Criteria
* Received a bone marrow transplant
* Active oncological condition
* Persistent right to left intracardiac shunt
* Cardiovascular surgery within the last 14 days
* Status asthmaticus
* Decision by primary care physician not to provide full support
* Received treatment with nitric oxide for inhalation or other investigational medications within 24 hours prior to study initiation, participating in surfactant trials
* Chronically ventilated
* Pregnant
16 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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James Baldassarre, MD
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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Chrildren's Hospital of Orange County
Orange, California, United States
Stanford University Medical Center
Stanford, California, United States
The Children's Hospital
Denver, Colorado, United States
Nemours Children's Clinic
Orlando, Florida, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States
University of Chicago, Children's Hospital
Chicago, Illinois, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
New York Presbyterian Hospital
New York, New York, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Children's Hospital
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
The Medical University of South Carolina
Charleston, South Carolina, United States
University of Virginia Pediatric Critical Care
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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INOT-11
Identifier Type: -
Identifier Source: org_study_id
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