Bronchiolitis7HSinEDNCT02253576
Inhaled Hypertonic Saline for Bronchiolitis
A study testing inhaled 7% hypertonic saline and inhaled nebulized normal saline in people with Bronchiolitis, run by Queen's University at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 weeks to 24 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- inhaled 7% hypertonic saline and inhaled nebulized normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesCanada
- Study dates
- Jun 2014to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Royal Victoria Regional Health Centre
Barrie, Ontario, L4N 6S7
Southeastern Ontario Health Sciences Centre
Kingston, Ontario, K7L2V6
Victoria General Hospital
Victoria, British Columbia, V8Z 6R5
About this study
Official title: 7% Hypertonic Saline to Treat Bronchiolitis in the Emergency Department
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.
Read the detailed description
Children under age 2 years presenting for unscheduled care to the ED with a diagnosis of moderately severe bronchiolitis (as defined by inclusion/exclusion criteria below) will be approached for entry into the study. Recruitment will only occur when Research Assistants are on duty, is projected to include regular working hours Monday-Friday as a minimum and will continue until the calculated sample size has been obtained (anticipated 12 months). Initial routine assessment by the ED staff will identify potential subjects and Research Assistants will be notified to apply the inclusion/exclusion criteria and obtain informed consent if appropriate. Recruited subjects will be randomized to receive treatment in a double blind fashion with inhalation of nebulized study solution containing either 7% hypertonic saline (HS, study group) or 0.9% saline (NS, control group). Each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) added by the ED staff. Each participant will remain on the same allocation throughout the protocol and receive 3 consecutive 4ml doses of the assigned study solution with salbutamol over a 1-hour period.
- Conditions
- Bronchiolitis
- Being tested
- inhaled 7% hypertonic saline, inhaled nebulized normal saline
- Keywords
- infant, bronchiolitis, hypertonic saline
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: inhaled nebulized normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 120 minutes after baseline pre-treatment
Secondary outcomes (3)
rates of admission to hospital
Measured: 7 days
length-of-stay of admitted patients
Measured: 28 days
rates of unscheduled return for respiratory illness to the ED
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2014
Why it stopped: Study not funded - never initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Michael Flavin, Queen's University
- Investigators
- Michael Flavin, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253576
- Sponsor's protocol ID
- Kuz-7HS
- Acronym
- 7HSinED
- Status last verified
- Nov 2015
- First submitted
- 29 Sep 2014
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7% Hypertonic Saline to Treat Bronchiolitis in the Emergency Department
- ClinicalTrials.gov ID
- NCT02253576
- Acronym / sponsor ID
- 7HSinED / Kuz-7HS
- Conditions
- Bronchiolitis
- Keywords
- infant, bronchiolitis, hypertonic saline
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not funded - never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2014 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Children under age 2 years presenting for unscheduled care to the ED with a diagnosis of moderately severe bronchiolitis (as defined by inclusion/exclusion criteria below) will be approached for entry into the study. Recruitment will only occur when Research Assistants are on duty, is projected to include regular working hours Monday-Friday as a minimum and will continue until the calculated sample size has been obtained (anticipated 12 months). Initial routine assessment by the ED staff will identify potential subjects and Research Assistants will be notified to apply the inclusion/exclusion criteria and obtain informed consent if appropriate. Recruited subjects will be randomized to receive treatment in a double blind fashion with inhalation of nebulized study solution containing either 7% hypertonic saline (HS, study group) or 0.9% saline (NS, control group). Each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) added by the ED staff. Each participant will remain on the same allocation throughout the protocol and receive 3 consecutive 4ml doses of the assigned study solution with salbutamol over a 1-hour period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inhaled 7% hypertonic saline | Experimental | Other: inhaled 7% hypertonic salineThree 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 |
| inhaled nebulized normal saline | Active comparator | Other: inhaled nebulized normal salineThree 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 |
Who may qualify
- Ages
- 4 weeks to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhaled 7% hypertonic salineThree 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 | Other | inhaled 7% hypertonic saline |
| inhaled nebulized normal salineThree 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 | Other | inhaled nebulized normal saline |
Primary outcome
The change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS),
Time frame: 120 minutes after baseline pre-treatment
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
3 secondary outcomes
rates of admission to hospital
Time frame: 7 days
length-of-stay of admitted patients
Time frame: 28 days
rates of unscheduled return for respiratory illness to the ED
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Flavin, MD principal investigator
Queen's University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inhaled 7% hypertonic saline and inhaled nebulized normal saline in people with Bronchiolitis, run by Queen's University at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS), (time frame: 120 minutes after baseline pre-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.