Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients

• ClinicalTrials.gov Identifier: NCT00116584
• Recruitment Status: Completed
• First Posted: June 30, 2005
• Results First Posted: May 20, 2020
• Last Update Posted: May 20, 2020
• Sponsor: University of Louisville
• Information provided by (Responsible Party): In K. Kim, University of Louisville

Tracking Information

• First Submitted Date: June 29, 2005
• First Posted Date: June 30, 2005
• Results First Submitted Date: August 19, 2013
• Results First Posted Date: May 20, 2020
• Last Update Posted Date: May 20, 2020
• Study Start Date: December 2004
• Actual Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 8, 2020)

Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes [ Time Frame: 240 Minutes ]

The Modified Wood's clinical Asthma Score is a score to measure severity of Asthma in children. There are 5 variables measured: oxygen saturation, inspiratory breath sounds, expiratory wheezing, accessory muscle involvement and cerebral function. Each variable is given a score of 0, 0.5, 1 or 2 with 2 being the most severe. The scores are combined from each variable to give a total. Total score ranges from 0 to 10, with a score of 10 (higher the score) indicating a worse outcome. We are reporting the degree of improvement in M-WCAS after assigned treatment.

• Original Primary Outcome Measures (submitted: June 29, 2005): modified Wood's Clinical Bronchiolitis Score (M-WCBS)

Current Secondary Outcome Measures (submitted: May 8, 2020)

• Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times [ Time Frame: 0, 60, 120, 180 and 240 min ]
  The Modified Wood's Clinical Bronchiolitis Score is based on a rating of saturated oxygen, inspiratory breath sounds, expiratory wheezing, accessory muscle use, cerebral function and wheezing. Each variable is rated 0, 0.5, 1, or 2. The total range of score is 0 to 2, with 2 (higher the score) indicating a worse outcome. For this outcome, a negative difference between groups represents an improvement.
• Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times [ Time Frame: 0, 60, 120, 180 and 240 mins ]
  The RDAI is an assessment instrument for respiratory distress. Patients are assigned a point value based on Wheezing (on expiration, inspiration and location) and Retractions (local of supraclavicular, intercostal and subcostal). Each subcategory is assigned a value of 0-4. The subscores are summed to give a total score for each variable (wheezing and retractions). The total score range for wheezing is 0 to 8, with 8 (higher the score) indicating a worse outcome. The total score range for retractions is 0 to 9, with 9 (higher the score) indicating a worse outcome. We are reporting the difference in score between the groups at various times, not a change from an earlier time. A positive value represents an improvement in the Heliox vs the Oxygen groups.

Original Secondary Outcome Measures (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: 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Bronchiolitis

Intervention

• Drug: heliox
  continuous heliox therapy
• Drug: oxygen
  continuous oxygen therapy

Study Arms

• heliox
  heliox-driven nebulizations for children with moderate to severe bronchiolitis
  Intervention: Drug: heliox
• oxygen
  oxygen-driven nebulizations for children with moderate to severe bronchiolitis
  Intervention: Drug: oxygen

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 18, 2012): 72
• Original Enrollment (submitted: June 29, 2005): 100
• Actual Study Completion Date: October 2011
• Actual Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Months to 12 Months (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00116584
• Other Study ID Numbers: GRNT040954; GRNT040954; G040954 ( Other Grant/Funding Number: Praxair Healthcare )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: In K. Kim, University of Louisville
• Original Responsible Party: Not Provided
• Current Study Sponsor: University of Louisville
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Louisville
• Verification Date: May 2020