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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
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Heliox Driven Racemic Epinephrine Nebulization in the Treatment of Moderate to Severe Bronchiolitis in Pediatric Emergency Department Patients

Resource links provided by NLM:


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 ]

Enrollment: 72
Study Start Date: December 2004
Study Completion Date: October 2011
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by University of Louisville

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00116584     History of Changes
Other Study ID Numbers: GRNT040954, GRNT040954, G040954
Study First Received: June 29, 2005
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Louisville:
heliox
bronchiolitis
racemic epinephrine

Additional relevant MeSH terms:
Bronchiolitis
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Epinephrine
Epinephryl borate
Racepinephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 20, 2014