NCT02253576

Brief Summary

Study Design: This randomized, double blind, controlled, multi-centre study will occur in the Emergency Department, hospital-based Urgent Care Centre or paediatric outpatient clinics (collectively "ED") of 3 General Hospitals in Ontario and 1 in British Columbia.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

3 active sites

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

Same day

First QC Date

September 29, 2014

Last Update Submit

November 12, 2015

Conditions

Bronchiolitis

Keywords

infantbronchiolitishypertonic saline

Outcome Measures

Primary Outcomes (1)

  • The change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS),

    The response to treatment is determined by using the Respiratory Distress Assessment Instrument(RDAI) score and respiratory rate to calculate the Respiratory Assessment Change Score (RACS) i.e. RDAI score before minus RDAI score after treatment

    120 minutes after baseline pre-treatment

Secondary Outcomes (3)

  • rates of admission to hospital

    7 days

  • length-of-stay of admitted patients

    28 days

  • rates of unscheduled return for respiratory illness to the ED

    14 days

Study Arms (2)

inhaled 7% hypertonic saline

EXPERIMENTAL

Three consecutive 4ml doses of 7% NaCl solution with salbutamol(0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) nebulized over a 1-hour period

Other: inhaled 7% hypertonic saline

inhaled nebulized normal saline

ACTIVE COMPARATOR

Three consecutive 4ml doses of 0.9 NaCl solution added to salbutamol(0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) nebulized over a 1-hour period

Other: inhaled nebulized normal saline

Interventions

inhaled 7% hypertonic salineOTHER

Three consecutive doses of 4 ml of 7% hypertonic saline added to salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution over 1 hour

inhaled 7% hypertonic saline
inhaled nebulized normal salineOTHER

Three consecutive doses of 4 ml of 0.9% NaCl added to salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution over 1 hour

inhaled nebulized normal saline

Eligibility Criteria

Age4 Weeks - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age under 2 years
  • History of viral upper respiratory infection within previous 7 days
  • Wheezing or crackles detected on chest auscultation
  • Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen saturation (SaO2) of 94% or less in room air.

You may not qualify if:

  • History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks.
  • Severe illness at presentation as defined by any of the following Respiratory rate greater than 80/min SaO2 less than 88% in room air Need for assisted ventilation Use of nebulized HS within previous 12 hours Previous enrollment in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Victoria General Hospital

Victoria, British Columbia, V8Z 6R5, Canada

Location

Royal Victoria Regional Health Centre

Barrie, Ontario, L4N 6S7, Canada

Location

Southeastern Ontario Health Sciences Centre

Kingston, Ontario, K7L2V6, Canada

Location

MeSH Terms

Conditions

Bronchiolitis

Interventions

InhalationSaline Solution, Hypertonic

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaHypertonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Michael Flavin, MD

    Queen's University

    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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 1, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2014

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations

CA(3)