Hypertonic Saline for Acute Bronchiolitis
|ClinicalTrials.gov Identifier: NCT01247064|
Recruitment Status : Completed
First Posted : November 24, 2010
Results First Posted : August 19, 2014
Last Update Posted : August 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis, Viral Saline Solution, Hypertonic||Drug: Nebulized 3% saline Drug: Nebulized 0.9% Normal Saline||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Nebulized Hypertonic Saline for Acute Bronchiolitis in the Emergency Department|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
|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
- 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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247064
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Joseph Zorc, MD, MSCE||Children's Hospital of Philadelphia|
|Principal Investigator:||Todd Florin, MD||Children's Hospital of Philadelphia|