Hypertonic Saline for Acute Bronchiolitis
Condition: Bronchiolitis, Viral; Saline Solution, Hypertonic
MeSH terms: Bronchiolitis; Bronchiolitis, Viral
Study type: Interventional
Phase: Phase 4

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 description: 
      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
      bronchiolitis. This study did not find a difference between epinephrine diluted in normal
      saline compared to epinephrine diluted in 3% HS. Despite no effect on clinical score, the
      investigators did note a trend toward decreased rates of hospitalization. Furthermore, since
      this was the first ED study and the first negative study, the authors concluded that further
      investigation is necessary to determine if HS has a role in the management of acute
      bronchiolitis.

      The purpose of the current study is to determine whether nebulized 3% HS improves respiratory
      distress in children 2-23 months presenting to the ED with acute bronchiolitis with
      persistent respiratory distress after initial therapy with a trial of nebulized albuterol.

      Given the tremendous clinical and financial burden of bronchiolitis, any effective therapy,
      particularly one that is inexpensive, has the potential to result in significant health care
      savings. If nebulized 3% HS improved clinical scores in the ED, this may provide an
      inexpensive, safe and effective therapy for children with bronchiolitis in the acute care
      setting.
    

Intervention name(s): Nebulized 3% saline; Nebulized 0.9% Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): 4 mL of nebulized 3% saline once; 4 mL of 0.9% nebulized normal saline once
Other intervention name(s): 3% Hypertonic Saline Solution for Inhalation; 0.9% Saline Solution for Inhalation
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bronchiolitis; Hypertonic Saline