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Heliox-Driven Racemic Epinephrine Nebulization in Treatment of Moderate to Severe Bronchiolitis in Pediatric ED Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00116584
Recruitment Status : Completed
First Posted : June 30, 2005
Last Update Posted : June 18, 2013
Information provided by (Responsible Party):
University of Louisville

Brief Summary:
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 or disease Intervention/treatment Phase
Bronchiolitis Drug: heliox Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Heliox Driven Racemic Epinephrine Nebulization in the Treatment of Moderate to Severe Bronchiolitis in Pediatric Emergency Department Patients
Study Start Date : December 2004
Actual Primary Completion Date : March 2008
Actual Study Completion Date : October 2011

Arm Intervention/treatment
heliox-driven nebulizations for children with moderate to severe bronchiolitis
Drug: heliox
continuous heliox therapy

Primary Outcome Measures :
  1. modified Wood's Clinical Bronchiolitis Score (M-WCBS) [ Time Frame: 0, 60, 120, 180 and 240 min ]

Secondary Outcome Measures :
  1. hospitalization rates [ Time Frame: discharge ]
  2. change in oxygen saturation [ Time Frame: 0, 60, 120, 180, 240 min ]
  3. duration of Pediatric Intensive Care Unit (PICU) stay [ Time Frame: discharge ]
  4. duration of total hospital stay [ Time Frame: at discharge ]
  5. patient intolerance of non-rebreathing mask [ Time Frame: entire study ]
  6. intravenous beta agonist requirement [ Time Frame: entire study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Any child 2-12 months old seen in the emergency department.
  • A clinical bronchiolitis score > 3 by modified Wood's Clinical Bronchiolitis Score (M-WCBS).
  • Diagnostic criteria of bronchiolitis includes tachypnea, cough, prolonged expiratory phase, wheezing, rales, chest retractions, and hyperinflation of lungs on chest radiograph. After consenting a patient to the study, respiratory syncytial virus (RSV) infection will be tested by rapid enzyme-linked immunoabsorbent assay of nasal secretions.

Exclusion Criteria:

  • No child will be excluded based on race or gender
  • Patients under the age of 2 months or greater than 12 months
  • Patients with cyanotic heart disease
  • Patients with lobar pneumonia, defined by results of chest radiographs.
  • The presence of interstitial disease or diffuse patchy marking consistent with atelectasis on chest radiographs will not exclude patients.
  • Patients with croup.
  • Patients with foreign body aspiration.
  • Patients with history of cystic fibrosis, bronchopulmonary dysplasia or other chronic lung disease.
  • Patients with liver or renal disease.
  • Patients with sickle cell anemia.
  • Patients requiring mechanical ventilation.
  • Patients who develop supraventricular tachycardia secondary to racemic epinephrine administration.
  • Patients with tracheomalacia or bronchomalacia.
  • Patients who had received bronchodilators within 2 hours of initiation of the study.
  • Patients who had received systemic corticosteroids within 72 hours of enrollment
  • Patients who suffered from persistent airway hyperreactivity in the 3 months before the study.
  • Patients who do not tolerate the nasal cannulae for 45 out of 60 minutes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00116584

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United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
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Principal Investigator: In K Kim, MD University of Louisville, Dept. of Pediatrics, Div. of Pediatric Emergency Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Louisville Identifier: NCT00116584    
Other Study ID Numbers: GRNT040954
G040954 ( Other Grant/Funding Number: Praxair Healthcare )
First Posted: June 30, 2005    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013
Keywords provided by University of Louisville:
racemic epinephrine
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents