The Use of Heliox Driven Racemic Epinephrine Nebulization in the Treatment of Moderate to Severe Bronchiolitis in Pediatric Emergency Department Patients - Full Text View

Sponsored by:	University of Louisville
Information provided by:	University of Louisville
ClinicalTrials.gov Identifier:	NCT00116584

Purpose

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

Drug Information available for: Epinephrine Epinephrine bitartrate Heliox

U.S. FDA Resources

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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

hospitalization rates [ Time Frame: discharge ] [ Designated as safety issue: No ]
change in oxygen saturation [ Time Frame: 0, 60, 120, 180, 240 min ] [ Designated as safety issue: No ]
duration of Pediatric Intensive Care Unit (PICU) stay [ Time Frame: discharge ] [ Designated as safety issue: No ]
duration of total hospital stay [ Time Frame: at discharge ] [ Designated as safety issue: No ]
patient intolerance of non-rebreathing mask [ Time Frame: entire study ] [ Designated as safety issue: No ]
intravenous beta agonist requirement [ Time Frame: entire study ] [ Designated as safety issue: No ]

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	Drug: heliox continuous heliox therapy

Eligibility

Ages Eligible for Study:	2 Months to 12 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116584

Locations

United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202

Sponsors and Collaborators

University of Louisville

Investigators

Principal Investigator:

In K Kim, MD

University of Louisville, Dept. of Pediatrics, Div. of Pediatric Emergency Medicine

More Information

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
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Louisville:

heliox
bronchiolitis
racemic epinephrine

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases

Bronchiolitis
Emergencies
Bronchitis
Epinephrine

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Disease Attributes
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Bronchial Diseases
Sympathomimetics
Physiological Effects of Drugs
Anti-Asthmatic Agents

Cardiovascular Agents
Adrenergic Agonists
Pharmacologic Actions
Pathologic Processes
Mydriatics
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009