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

S

Sheikh Khalifa Medical City

Status and phase

Completed
Phase 3
Phase 2

Conditions

Bronchiolitis

Treatments

Drug: 3 % hypertonic saline

Study type

Interventional

Funder types

Other

Identifiers

NCT00151905
RC-09

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

Under 18 months old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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