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The Use of an Inhaled Salt Solution to Treat Viral Lung Infections in Infants.

Nebulized Hypertonic Saline in the Treatment of Bronchiolitis in Infants

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00151905
Enrollment
Unknown
Registered
2005-09-09
Start date
2003-11-30
Completion date
2006-09-30
Last updated
2007-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

Keywords

bronchiolitis, hypertonic saline

Brief summary

Bronchiolitis is a common viral lung infection in infants. Standard treatment often includes the use of inhaled medications which are usually first mixed with a standard salt solution. Inhalation of a more concentrated salt solution (hypertonic saline) has been successfully used to treat other types of lung disease in children and adults. The purpose of this study is to see if using inhaled hypertonic saline helps infants with bronchiolitis get better more quickly.

Detailed description

Bronchiolitis is a common illness in infants and is associated with a significant morbidity. Standard therapy is controversial and largely ineffective; care is mostly supportive although nebulized medications continue to be commonly used. These medications are typically mixed with normal saline to produce a sufficient volume for efficient nebulization. Inhaled hypertonic saline has been used to aid airway clearance in children with cystic fibrosis. It has also been used, in low dose, in two small studies in children with bronchiolitis. The current study is a randomized, double-blind, placebo-controlled, multi-center trial comparing frequent dosing with 3% hypertonic saline compared to normal saline in the treatment of infants hospitalized with bronchiolitis.

Interventions

DRUG3 % hypertonic saline

Sponsors

Sheikh Khalifa Medical City
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Months
Healthy volunteers
No

Inclusion criteria

* Corrected age maximum 18 months, plus * History of preceding viral upper respiratory tract infection, plus * Presence of wheezing and/or crackles on auscultation, plus * Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater, or oxygen saturation of 93% or less in room air, plus * Admitted to hospital

Exclusion criteria

* Prior history of wheezing, or * History of chronic cardiopulmonary disease or immunodeficiency, or * Critical illness at presentation requiring admission to ICU, or * Use of nebulized hypertonic saline within previous 12 hours, or * Prematurity (gestational age 34 weeks or less).

Design outcomes

Primary

MeasureTime frame
Length of stay.

Countries

Canada, United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026