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Completed

NCT Number: NCT00619918

Nebulized Hypertonic Saline for Bronchiolitis

This study aims to examine the effect of nebulized 3% hypertonic saline in the treatment of viral bronchiolitis. The investigators hypothesize that nebulized 3% saline will decrease rate of hospital admission, decrease clinical severity scores, and decrease length of stay.

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Key information

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Childrens Hospital Los Angeles, Los Angeles, California, United States

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About this study

Bronchiolitis is the most common viral respiratory infection in young children and infants. It is responsible for hundreds of thousands of outpatient visits and hospitalizations every year. Hypertonic saline may decrease swelling in the lung tissue, improve the patient's ability to clear secretions, and decrease nasal congestion. Hypertonic saline nebulizations have already been used effectively in patients with cystic fibrosis and in a few small trials on infants with bronchiolitis. Patients who come to the emergency department or inpatient ward of two urban free-standing pediatric hospitals in California between December and April and are diagnosed with bronchiolitis will be randomized into two groups- the control group will receive nebulized 0.9% normal saline, while the study group will receive nebulized 3% hypertonic saline. Nebulizations will be pretreated with albuterol, to prevent the theoretical risk of increased wheezing in patients with undiagnosed underlying asthma. Patients will be given up to 3 nebulizations in the emergency department, after which time the attending physician will decide whether admission to the hospital is required. Patients who are admitted will continue to receive the same nebulized treatment every 8 hours until discharged. Additional interventions such as epinephrine treatments and antibiotics can be ordered as indicated by the patient care team.

Investigators will measure symptom severity before and after treatments using the respiratory distress assessment instrument (RDAI). The investigators will compare rates of being admitted to the hospital in each group. The investigators will also compare RDAI scores, average length of stay, number of additional respiratory treatments needed, number of hours requiring oxygen, amount of IV fluid needed, and frequency of adverse effects. The investigators hypothesize that nebulized hypertonic saline will be a safe, cost-effective, and efficacious therapy which can be utilized in the outpatient setting to prevent hospital admission, as well as decrease length of stay for patients who require admission. Given the significant disease burden of viral bronchiolitis, the potential impact is substantial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnosis of viral bronchiolitis
  • between November and April

Exclusion criteria

  • prematurity < 34 weeks
  • chronic lung disease
  • congenital heart disease
  • history of wheezing, asthma or albuterol use
  • tracheostomy status
  • need for intensive care of assisted ventilation

Treatment and study plan

Nebulized 3% saline

Drug

4 ml inhaled q8h

Other names: 3% saline, Hypertonic saline, NaCl 3%

Nebulized 0.9% saline

Drug

normal saline

Other names: Normal saline, NS, NaCl 0.9%

Primary outcomes

  1. Admission Rate

    Time frame: 1 day

    Patients enrolled in the ED who required inpatient admission. Patients who required admission but were transferred to another facility due to lack of available beds were considered admitted for this outcome. Note, neither study site has an observation unit.

  2. Length of Stay

    Time frame: 1 month

    Length of stay defined as date of discharge minus date of admission (whole days)

  3. Change in RDAI Score

    Time frame: 1 Hour

    The Respiratory Distress Assessment Instrument (RDAI) is a respiratory severity score ranging from a low score of 0 to maximum score of 17. Lower scores indicate more mild symptoms; mild disease (0-6), moderate disease (7-11), and severe (12-17). A decrease in score of 2 is considered clinically significant improvement.

Secondary outcomes

  1. Hours of Oxygen Use

    Time frame: 14 days

    Hours requiring supplemental oxygen for admitted patients.

  2. IV Fluid Use

    Time frame: 14 days

    IV fluid volume administered during entire hospitalization, in mL/kg

  3. Number of Participants With Supplemental Medication Use

    Time frame: 14 days

    patients who received supplemental albuterol, ipratropium, or epinephrine inhaled treatment (other than pre-treatment for study med)

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • Thrasher Research Fund
  • UCSF Benioff Children's Hospital Oakland

Registry information

Official study title

Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 21, 2008
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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