NCT00151905

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2003

Typical duration for phase_2

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

May 7, 2007

Status Verified

September 1, 2005

First QC Date

September 7, 2005

Last Update Submit

May 4, 2007

Conditions

Bronchiolitis

Keywords

bronchiolitishypertonic saline

Outcome Measures

Primary Outcomes (1)

  • Length of stay.

Interventions

3 % hypertonic salineDRUG

Eligibility Criteria

AgeUp to 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Victoria General Hospital

Victoria, British Columbia, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Sheikh Khalifa Medical City

Abu Dhabi, Abu Dhabi Emirate, 51900, United Arab Emirates

Location

MeSH Terms

Conditions

Bronchiolitis

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Brian A Kuzik, MD, FRCP

    Sheikh Khalifa Medical City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 9, 2005

Study Start

November 1, 2003

Study Completion

September 1, 2006

Last Updated

May 7, 2007

Record last verified: 2005-09

Locations

CA(2)AE(1)