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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT00116584
First received: June 29, 2005
Last updated: June 17, 2013
Last verified: June 2013

June 29, 2005
June 17, 2013
December 2004
March 2008   (final data collection date for primary outcome measure)
modified Wood's Clinical Bronchiolitis Score (M-WCBS) [ Time Frame: 0, 60, 120, 180 and 240 min ] [ Designated as safety issue: No ]
modified Wood's Clinical Bronchiolitis Score (M-WCBS)
Complete list of historical versions of study NCT00116584 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Heliox-Driven Racemic Epinephrine Nebulization in Treatment of Moderate to Severe Bronchiolitis in Pediatric ED Patients
The Use of Heliox Driven Racemic Epinephrine Nebulization in the Treatment of Moderate to Severe Bronchiolitis in Pediatric Emergency Department Patients

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Bronchiolitis
Drug: heliox
continuous heliox therapy
heliox
heliox-driven nebulizations for children with moderate to severe bronchiolitis
Intervention: Drug: heliox
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
October 2011
March 2008   (final data collection date for primary outcome measure)

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.
Both
2 Months to 12 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00116584
GRNT040954, GRNT040954, G040954
No
University of Louisville
University of Louisville
Not Provided
Principal Investigator: In K Kim, MD University of Louisville, Dept. of Pediatrics, Div. of Pediatric Emergency Medicine
University of Louisville
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP