Nebulized Hypertonic Saline for Bronchiolitis

NCT ID: NCT00619918

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 447 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2011-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nebulized 3% Saline

3% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.

Group Type: EXPERIMENTAL

Nebulized 3% saline

Intervention Type: DRUG

4 ml inhaled q8h

Nebulized 0.9% Saline

0.9% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.

Group Type: PLACEBO_COMPARATOR

Nebulized 0.9% saline

Intervention Type: DRUG

normal saline

Interventions

Nebulized 3% saline

4 ml inhaled q8h

Intervention Type: DRUG

Nebulized 0.9% saline

normal saline

Intervention Type: DRUG

Other Intervention Names

3% saline; Hypertonic saline; NaCl 3%; Normal saline; NS; NaCl 0.9%

Eligibility Criteria

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

• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role: collaborator

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Susan Wu

Assistant Professor of Clinical Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Childrens Hospital Los Angeles/University of Southern California

Locations

Childrens Hospital Los Angeles

Los Angeles, California, United States

Children's Hospital & Research Center at Oakland

Oakland, California, United States

Countries

United States

References

Wu S, Baker C, Lang ME, Schrager SM, Liley FF, Papa C, Mira V, Balkian A, Mason WH. Nebulized hypertonic saline for bronchiolitis: a randomized clinical trial. JAMA Pediatr. 2014 Jul;168(7):657-63. doi: 10.1001/jamapediatrics.2014.301.

Reference Type: DERIVED

PMID: 24862623 (View on PubMed)

Other Identifiers

CCI-06-00271

Identifier Type: -

Identifier Source: org_study_id