NCT00729274

Brief Summary

The purpose of this study is to determine whether nebulized hypertonic saline solution reduces the admission rate 48 hours after initial treatment in the emergency department, when compared to normal saline solution (placebo). We hypothesise that patients with bronchiolitis who receive nebulized hypertonic saline solution will have less respiratory distress, less duration of symptoms and therefore less risk of being hospitalized than those receiving normal saline solution.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

August 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
3.2 years until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

August 5, 2008

Last Update Submit

September 4, 2015

Conditions

Acute Viral Bronchiolitis.

Outcome Measures

Primary Outcomes (1)

  • Hospitalization Rate

    After 48 hours of treatment in the emergency department

Secondary Outcomes (1)

  • The IRAS (Infant Respiratory Assessment Score) will be measured after each Treatment to verify improvement.

    30 minutes after each nebulization

Study Arms (2)

hypertonic saline solution

ACTIVE COMPARATOR

Hypertonic Saline 3% solution alone.

Drug: normal saline solution

nebulized normal saline solution

PLACEBO COMPARATOR

2 nebulisation with 30 minute interval (max 4ml)

Drug: normal saline solution

Interventions

normal saline solutionDRUG

Two 4ml nebulizations with 30 minute interval

Also known as: Physiologic saline solution
hypertonic saline solutionnebulized normal saline solution

Eligibility Criteria

Age6 Weeks - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • clinical diagnosis of viral bronchiolitis
  • Age 6 weeks to 12 months
  • Clinical Score IRAS \>3 and \<8

You may not qualify if:

  • prematurity \<30 weeks
  • younger than 6 weeks of age
  • chronic lung disease
  • immunosuppression.
  • History of wheezing or asthma.
  • Clinical Score IRAS \>9
  • parents refuse study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laval University Hospital Center

Québec, Quebec, G1V 4G2, Canada

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Guimont Chantal, MD, PhD.

    Laval University Hospital Center, Quebec, Canada.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 7, 2008

Study Start

November 1, 2011

Primary Completion

May 1, 2012

Study Completion

April 1, 2014

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

CA(1)