Clinical Trial: Hypertonic Saline for Acute Bronchiolitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Nebulized Hypertonic Saline for Acute Bronchiolitis in the Emergency Department

Brief Summary: The purpose of this study is to determine whether nebulized 3% hypertonic saline (HS) improves respiratory distress in children 2-23 months presenting to the emergency department (ED) with acute bronchiolitis with persistent respiratory distress after initial therapy with a trial of nebulized albuterol.

Detailed Summary:

Acute bronchiolitis is the most frequent cause of infant hospitalization in the United States. Bronchiolitis typically refers to a viral lower respiratory tract infection during the first two years of life manifesting as a constellation of clinical symptoms including wheezing, cough and respiratory distress. In addition to a tremendous disease burden, bronchiolitis admissions in the United States cost more than $500 million each year.

The primary pathophysiologic processes in bronchiolitis include airway wall and peribronchial inflammation, increased mucous production, sloughing of necrotic epithelial cells, and impaired airway clearance. These processes result in airway obstruction, gas trapping, atelectasis and impaired gas exchange. Standard therapies for bronchiolitis remain supportive, including maintaining hydration and nutrition, ensuring adequate oxygenation, and physical suctioning of the nasal airways to clear secretions. Therapies such as the bronchodilator albuterol, although commonly used in standard practice, have not been proven to impact progression of disease or improve long-term outcomes of bronchiolitis.

Nebulized hypertonic saline (HS) has been shown to increase mucociliary clearance in the airways of individuals with healthy lungs. In addition nebulized HS increases airway clearance for disease processes including asthma, cystic fibrosis and bronchiectasis. A recent Cochrane review examined 4 small studies that suggest that nebulized 3% HS may reduce length of hospital stay and improve clinical severity scores in infants with acute viral bronchiolitis. None of these studies have explored the use of nebulized HS in the emergency department (ED). A recent study examined the use of a single nebulized treatment of epinephrine mixed in 3% HS in 46 infants less than 12 months presenting to the ED with bronch
Sponsor: Children's Hospital of Philadelphia

Current Primary Outcome: Respiratory Assessment Change Score (RACS) [ Time Frame: Baseline and 1 hour ]

The Respiratory Assessment Change Score (RACS) assesses change in respiratory status using the change in the Respiratory Distress Assessment Instrument (RDAI) and a standardized change in respiratory rate, with points being assigned by change increments of 10%. Thus, a change in respiratory rate of ≤5% from baseline counted as a change of 0 units, decrease/increase of 6% to 15% counted as improvement/deterioration of 1 unit, etc. The overall RACS is the arithmetic sum of the RDAI change and the standardized respiratory rate change between assessments with a decrease in RACS signifying improvement.


Original Primary Outcome: Respiratory Assessment Change Score/Change in RDAI Score [ Time Frame: 1 hour ]

Current Secondary Outcome:

  • Rate of Hospitalization [ Time Frame: 1 day ]
  • Respiratory Rate Change [ Time Frame: Baseline and 1 hour ]
  • Oxygen Saturation Change [ Time Frame: Baseline and 1 hour ]
  • Parental Perception of Improvement of Breathing After Study Medication [ Time Frame: 1 hour ]


Original Secondary Outcome:

  • Rate of Hospitalization [ Time Frame: 1 day ]
  • Vital Sign Changes (heart rate, respiratory rate) [ Time Frame: 1 hour ]
  • Pulse Oximetry [ Time Frame: 1 hour ]
  • Parental Perception of Improvement of Bronchiolitis Symptoms after Study Medication [ Time Frame: 5 days ]


Information By: Children's Hospital of Philadelphia

Dates:
Date Received: November 15, 2010
Date Started: October 2010
Date Completion:
Last Updated: July 31, 2014
Last Verified: July 2014