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

This study has been completed.
Information provided by (Responsible Party):
University of Louisville Identifier:
First received: June 29, 2005
Last updated: June 17, 2013
Last verified: June 2013
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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of Louisville:

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

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

Enrollment: 72
Study Start Date: December 2004
Study Completion Date: October 2011
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
heliox-driven nebulizations for children with moderate to severe bronchiolitis
Drug: heliox
continuous heliox therapy


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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00116584

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Louisville Identifier: NCT00116584     History of Changes
Other Study ID Numbers: GRNT040954
G040954 ( Other Grant/Funding Number: Praxair Healthcare )
Study First Received: June 29, 2005
Last Updated: June 17, 2013

Keywords provided by University of Louisville:
racemic epinephrine

Additional relevant MeSH terms:
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 processed this record on September 21, 2017