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

Bronchiolitis Clinical Trial

Official title:

The Use of Heliox Driven Racemic Epinephrine Nebulization in the Treatment of Moderate to Severe Bronchiolitis in Pediatric Emergency Department Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116584
• Other study ID #: GRNT040954
• Secondary ID: GRNT040954G04095
• Status: Completed
• Phase: Phase 3
• Start date: December 2004
• Est. completion date: October 2011

Study information

• Verified date: May 2020
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2011
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

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

Locations

Country	Name	City	State
United States	Kosair Children's Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

References & Publications (1)

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/archpediatric — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 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.	240 Minutes
Secondary	Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times	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.	0, 60, 120, 180 and 240 min
Secondary	Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times	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.	0, 60, 120, 180 and 240 mins