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Hypertonic Saline for Acute Bronchiolitis

This study has been completed.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia Identifier:
First received: November 15, 2010
Last updated: July 31, 2014
Last verified: July 2014
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.

Condition Intervention Phase
Bronchiolitis, Viral
Saline Solution, Hypertonic
Drug: Nebulized 3% saline
Drug: Nebulized 0.9% Normal Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nebulized Hypertonic Saline for Acute Bronchiolitis in the Emergency Department

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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 ]

Enrollment: 62
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nebulized 3% Saline Drug: Nebulized 3% saline
4 mL of nebulized 3% saline once
Other Name: 3% Hypertonic Saline Solution for Inhalation
Placebo Comparator: Nebulized 0.9% Normal Saline Drug: Nebulized 0.9% Normal Saline
4 mL of 0.9% nebulized normal saline once
Other Name: 0.9% Saline Solution for Inhalation

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.


Ages Eligible for Study:   2 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 8 weeks through 23 months
  • First episode of wheezing associated with respiratory distress and upper respiratory tract infection.
  • Respiratory Distress Assessment Instrument (RDAI) rating of ≥4 and ≤15 after initial albuterol nebulization per standard care
  • Pediatric Emergency Medicine (PEM) physician does not plan additional bronchodilator therapy within the hour after initial assessment.
  • Parental/guardian permission (informed consent)

Exclusion Criteria:

  • Subjects with prior history of wheezing or asthma or who have received bronchodilator therapy prior to the current illness
  • Chronic lung or heart disease
  • Critically ill infants requiring immediate airway stabilization
  • Non-English speaking parent/guardian
  • Inability to take nebulized medications
  Contacts and Locations
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Please refer to this study by its identifier: NCT01247064

United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Principal Investigator: Joseph Zorc, MD, MSCE Children's Hospital of Philadelphia
Principal Investigator: Todd Florin, MD Children's Hospital of Philadelphia
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Children's Hospital of Philadelphia Identifier: NCT01247064     History of Changes
Other Study ID Numbers: IRB 10-007460
Study First Received: November 15, 2010
Results First Received: March 14, 2014
Last Updated: July 31, 2014

Keywords provided by Children's Hospital of Philadelphia:
Hypertonic Saline

Additional relevant MeSH terms:
Bronchiolitis, Viral
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases
Pharmaceutical Solutions processed this record on March 28, 2017