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Sponsored by: |
University of Louisville |
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Information provided by: | University of Louisville |
ClinicalTrials.gov Identifier: | NCT00116584 |
The purpose of this study is to assess whether children with moderate to severe bronchiolitis treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven nebulization will have improvements in measurements of airway more rapidly than those treated with conventional air-oxygen driven nebulization.
Condition | Intervention | Phase |
---|---|---|
Bronchiolitis |
Drug: heliox |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | The Use of Heliox Driven Racemic Epinephrine Nebulization in the Treatment of Moderate to Severe Bronchiolitis in Pediatric Emergency Department Patients |
Estimated Enrollment: | 100 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | July 2009 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
heliox
heliox-driven nebulizations for children with moderate to severe bronchiolitis
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Drug: heliox
continuous heliox therapy
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Ages Eligible for Study: | 2 Months to 12 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Kentucky | |
Kosair Children's Hospital | |
Louisville, Kentucky, United States, 40202 |
Principal Investigator: | In K Kim, MD | University of Louisville, Dept. of Pediatrics, Div. of Pediatric Emergency Medicine |
Responsible Party: | University of Louisville ( In K. Kim, MD ) |
Study ID Numbers: | GRNT040954, GRNT040954 |
Study First Received: | June 29, 2005 |
Last Updated: | April 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00116584 History of Changes |
Health Authority: | United States: Food and Drug Administration |
heliox bronchiolitis racemic epinephrine |
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic beta-Agonists Adrenergic Agents Bronchial Diseases Bronchiolitis Anti-Asthmatic Agents Cardiovascular Agents Adrenergic Agonists Lung Diseases, Obstructive |
Mydriatics Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Vasoconstrictor Agents Emergencies Bronchitis Peripheral Nervous System Agents Epinephrine Bronchodilator Agents |
Respiratory System Agents Disease Attributes Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic Agonists Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Infections Respiratory Tract Diseases Therapeutic Uses Vasoconstrictor Agents Bronchitis |
Epinephrine Adrenergic alpha-Agonists Adrenergic beta-Agonists Sympathomimetics Bronchiolitis Anti-Asthmatic Agents Cardiovascular Agents Pharmacologic Actions Mydriatics Autonomic Agents Lung Diseases Emergencies Peripheral Nervous System Agents Bronchodilator Agents |