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

Further Study Details: 

Primary Outcomes: modified Wood''''s Clinical Bronchiolitis Score (M-WCBS)
Secondary Outcomes: hospitalization rates; change in oxygen saturation; duration of Pediatric Intensive Care Unit (PICU) stay; duration of total hospital stay; patient intolerance of non-rebreathing mask; intravenous beta agonist requirement
Expected Total Enrollment:  100

Ages Eligible for Study:  2 Months   -   12 Months,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00116584

In K Kim, MD      502-629-7212    in.kim@louisville.edu
Kendra L Sikes, BS in CE      502-629-7212    kendra.sikes@louisville.edu

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

Study chairs or principal investigators

In K Kim, MD,  Principal Investigator,  University of Louisville, Dept. of Pediatrics, Div. of Pediatric Emergency Medicine   

Study ID Numbers:  GRNT040954; GRNT040954
Record last reviewed:  January 2005
Last Updated:  June 30, 2005
Record first received:  June 29, 2005
ClinicalTrials.gov Identifier:  NCT00116584
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05