Hypertonic Saline for Acute Bronchiolitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01247064
First received: November 15, 2010
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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/Change in RDAI Score [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of Hospitalization [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Vital Sign Changes (heart rate, respiratory rate) [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Pulse Oximetry [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Parental Perception of Improvement of Bronchiolitis Symptoms after Study Medication [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Enrollment: 60
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.

  Eligibility

Ages Eligible for Study:   2 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247064

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

Publications:
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01247064     History of Changes
Other Study ID Numbers: IRB 10-007460
Study First Received: November 15, 2010
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 10, 2014