Clinical trial NCT00116584: Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients
Official title: The Use of Heliox Driven Racemic Epinephrine Nebulization in the Treatment of Moderate to Severe Bronchiolitis in Pediatric Emergency Department Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchiolitis
Keywords: heliox
bronchiolitis
racemic epinephrine
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2005-06-30
Enrollment: 72
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes
timeFrame: 240 Minutes
Secondary outcomes:
measure: Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times
timeFrame: 0, 60, 120, 180 and 240 min
measure: Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times
timeFrame: 0, 60, 120, 180 and 240 mins
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville, Dept. of Pediatrics, Div. of Pediatric Emergency Medicine
name: In K Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim IK, Phrampus E, Sikes K, Pendleton J, Saville A, Corcoran T, Gracely E, Venkataraman S. Helium-oxygen therapy for infants with bronchiolitis: a randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Dec;165(12):1115-22. doi: 10.1001/archpediatrics.2011.605.