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

NCT00116584 | Completed Phase 3 Results

• 2 other identifiers: GRNT040954G040954
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

heliox; bronchiolitis; racemic epinephrine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times

  0, 60, 120, 180 and 240 min

• Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times

  0, 60, 120, 180 and 240 mins

Study Arms (2)

heliox

OTHER

heliox-driven nebulizations for children with moderate to severe bronchiolitis

Drug: heliox

oxygen

OTHER

oxygen-driven nebulizations for children with moderate to severe bronchiolitis

Drug: oxygen

Interventions

heliox DRUG

continuous heliox therapy

heliox

oxygen DRUG

continuous oxygen therapy

oxygen

Eligibility Criteria

• Age: 2 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Related 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/archpediatrics.2011.605.

  PMID: 22147778 RESULT

MeSH Terms

Conditions

Bronchiolitis

Interventions

heliox; Oxygen

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Results Point of Contact

• Title: Dr. In Kim
• Organization: ULouisville

in.kim@louisville.edu

502-629-7212

Study Officials

• In K Kim, MD

  University of Louisville, Dept. of Pediatrics, Div. of Pediatric Emergency Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2005
• First Posted: June 30, 2005
• Study Start: December 1, 2004
• Primary Completion: March 1, 2008
• Study Completion: October 1, 2011
• Last Updated: May 20, 2020
• Results First Posted: May 20, 2020

Record last verified: 2020-05

Locations

US (1)