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

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ClinicalTrials.gov Identifier: NCT00116584
Recruitment Status : Completed
First Posted : June 30, 2005
Last Update Posted : June 18, 2013
Sponsor:
Information provided by (Responsible Party):
University of Louisville

Tracking Information
First Submitted Date  ICMJE June 29, 2005
First Posted Date  ICMJE June 30, 2005
Last Update Posted Date June 18, 2013
Study Start Date  ICMJE December 2004
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
modified Wood's Clinical Bronchiolitis Score (M-WCBS) [ Time Frame: 0, 60, 120, 180 and 240 min ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2005)
modified Wood's Clinical Bronchiolitis Score (M-WCBS)
Change History Complete list of historical versions of study NCT00116584 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heliox-Driven Racemic Epinephrine Nebulization in Treatment of Moderate to Severe Bronchiolitis in Pediatric ED Patients
Official Title  ICMJE The Use of Heliox Driven Racemic Epinephrine Nebulization in the Treatment of Moderate to Severe Bronchiolitis in Pediatric Emergency Department Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bronchiolitis
Intervention  ICMJE Drug: heliox
continuous heliox therapy
Study Arms  ICMJE heliox
heliox-driven nebulizations for children with moderate to severe bronchiolitis
Intervention: Drug: heliox
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2012)
72
Original Enrollment  ICMJE
 (submitted: June 29, 2005)
100
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00116584
Other Study ID Numbers  ICMJE GRNT040954
GRNT040954
G040954 ( Other Grant/Funding Number: Praxair Healthcare )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: In K Kim, MD University of Louisville, Dept. of Pediatrics, Div. of Pediatric Emergency Medicine
PRS Account University of Louisville
Verification Date June 2013

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