Title
The Use of an Inhaled Salt Solution to Treat Viral Lung Infections in Infants.
Nebulized Hypertonic Saline in the Treatment of Bronchiolitis in Infants
Phase
Phase 2/Phase 3Lead Sponsor
Sheikh Khalifa Medical CityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
BronchiolitisIntervention/Treatment
sodium chloride ...Study Participants
NoneBronchiolitis 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.
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.
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).
