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
  Purpose

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.


Condition Intervention Phase
Bronchiolitis
Drug: 3 % hypertonic saline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Nebulized Hypertonic Saline in the Treatment of Bronchiolitis in Infants

Resource links provided by NLM:


Further study details as provided by Sheikh Khalifa Medical City:

Primary Outcome Measures:
  • Length of stay.

Study Start Date: November 2003
Estimated Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   up to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151905

Locations
Canada, British Columbia
Victoria General Hospital
Victoria, British Columbia, Canada
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
United Arab Emirates
Sheikh Khalifa Medical City
Abu Dhabi, United Arab Emirates, 51900
Sponsors and Collaborators
Sheikh Khalifa Medical City
Investigators
Principal Investigator: Brian A Kuzik, MD, FRCP Sheikh Khalifa Medical City
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00151905     History of Changes
Other Study ID Numbers: RC-09
Study First Received: September 7, 2005
Last Updated: May 4, 2007
Health Authority: United Arab Emirates: General Authority for Health Services for Abu Dhabi

Keywords provided by Sheikh Khalifa Medical City:
bronchiolitis
hypertonic saline

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 21, 2014