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

This study has been completed.
Sponsor:
Information provided by:
Sheikh Khalifa Medical City
ClinicalTrials.gov Identifier:
NCT00151905
First received: September 7, 2005
Last updated: May 4, 2007
Last verified: September 2005

September 7, 2005
May 4, 2007
November 2003
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Length of stay.
Same as current
Complete list of historical versions of study NCT00151905 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Bronchiolitis
Drug: 3 % hypertonic saline
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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September 2006
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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).
Both
up to 18 Months
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United Arab Emirates
 
NCT00151905
RC-09
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Sheikh Khalifa Medical City
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Principal Investigator: Brian A Kuzik, MD, FRCP Sheikh Khalifa Medical City
Sheikh Khalifa Medical City
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP