Acute Viral Bronchiolitis.NCT00729274
HYPERTONIC SALINE IN ACUTE VIRAL BRONCHIOLITIS: A RANDOMIZED CLINICAL TRIAL
A study testing normal saline solution in people with Acute Viral Bronchiolitis., run by Laval University at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 weeks to 12 months
- Conditions the study is for
- Acute Viral Bronchiolitis.
- What is being tested?
- normal saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Apr 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 6 weeks to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinical diagnosis of viral bronchiolitis
- Age 6 weeks to 12 months
- Clinical Score IRAS >3 and <8
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Acute viral bronchiolitis is the principal lower respiratory tract infection in infants worldwide, 10% of canadian infants are affected each year. It is characterized by a first episode of difficulty to breathe, preceded by symptoms of fever, rhinorrhea and cough. The only accepted treatment for bronchiolitis is nasal cleaning, hydration and oxygen administration. Multiple studies have documented variation in diagnostic testing, clinical scores used and different treatment modalities. This suggests a lack of consensus on the diagnosis, on criteria for hospitalization and on treatment. Nebulized 3% hypertonic saline solution has been proposed as a potential treatment for the reduction in the severity of respiratory symptoms and the rate of admission in bronchiolitis, it has never been studied alone and the effect on the rate of admission has been little studied.
We propose a randomized double blind multicenter clinical trial on infants 6 weeks to 12 months old with moderate or severe bronchiolitis, in 9 emergency departments of hospitals situated in different provinces across Canada, during 3 winter seasons. We hypothesise that infants with bronchiolitis treated with nebulized hypertonic 3% saline solution would have less risk of being hospitalized and would have shorter and less intense respiratory symptoms than those infants treated with nebulized normal saline solution. Our principal objective is to determine if nebulized 3% hypertonic saline solution reduces admission rate 48 hours after treatment compared to placebo. Secondary objectives are to compare between groups intensity of respiratory symptoms measured by different clinical scores (RDAI,PRAM, PASS and IRAS), duration of symptoms, length of hospital stay, added secondary effects and subsequent office visits for the same problem.
Comparatively to other therapies already studied such as (dexamethasone and epinephrine), hypertonic 3% saline constitutes an interesting choice due to the absence of potential secondary effects. Our study will try to optimize the utilization of hospital resources involved in the treatment of bronchiolitis. Infants suffering from this disease could therefore profit from better treatments which will be reflected in a better condition, life quality and consequently those of their parents.
- Conditions
- Acute Viral Bronchiolitis.
- Being tested
- normal saline solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal saline solutionDrug
Also called Physiologic saline solution
Two 4ml nebulizations with 30 minute interval
| Study group | Role | What they receive |
|---|---|---|
| hypertonic saline solution | Active comparator | Hypertonic Saline 3% solution alone. Receives: Drug: normal saline solution |
| nebulized normal saline solution | Placebo comparator | 2 nebulisation with 30 minute interval (max 4ml) Receives: Drug: normal saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization Rate
Measured: 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.
Measured: 30 minutes after each nebulization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startNov 2011
- Primary completionMay 2012 (estimated)
- Study completionApr 2014 (estimated)
Why it stopped: Was not approved by funding organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Viral Bronchiolitis.Studies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Centre de Recheche du Centre Hospitalier Université Laval
- Investigators
- Guimont Chantal, MD, PhD., Principal investigator, Laval University Hospital Center, Quebec, Canada.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729274
- Sponsor's protocol ID
- 222207
- Status last verified
- Sep 2015
- First submitted
- 5 Aug 2008
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPERTONIC SALINE IN ACUTE VIRAL BRONCHIOLITIS: A RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT00729274
- Acronym / sponsor ID
- 222207
- Conditions
- Acute Viral Bronchiolitis.
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Was not approved by funding organization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Centre de Recheche du Centre Hospitalier Université Laval
- Study start
- Nov 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 7 Aug 2008 (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.
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.
Detailed description
Acute viral bronchiolitis is the principal lower respiratory tract infection in infants worldwide, 10% of canadian infants are affected each year. It is characterized by a first episode of difficulty to breathe, preceded by symptoms of fever, rhinorrhea and cough. The only accepted treatment for bronchiolitis is nasal cleaning, hydration and oxygen administration. Multiple studies have documented variation in diagnostic testing, clinical scores used and different treatment modalities. This suggests a lack of consensus on the diagnosis, on criteria for hospitalization and on treatment. Nebulized 3% hypertonic saline solution has been proposed as a potential treatment for the reduction in the severity of respiratory symptoms and the rate of admission in bronchiolitis, it has never been studied alone and the effect on the rate of admission has been little studied.
We propose a randomized double blind multicenter clinical trial on infants 6 weeks to 12 months old with moderate or severe bronchiolitis, in 9 emergency departments of hospitals situated in different provinces across Canada, during 3 winter seasons. We hypothesise that infants with bronchiolitis treated with nebulized hypertonic 3% saline solution would have less risk of being hospitalized and would have shorter and less intense respiratory symptoms than those infants treated with nebulized normal saline solution. Our principal objective is to determine if nebulized 3% hypertonic saline solution reduces admission rate 48 hours after treatment compared to placebo. Secondary objectives are to compare between groups intensity of respiratory symptoms measured by different clinical scores (RDAI,PRAM, PASS and IRAS), duration of symptoms, length of hospital stay, added secondary effects and subsequent office visits for the same problem.
Comparatively to other therapies already studied such as (dexamethasone and epinephrine), hypertonic 3% saline constitutes an interesting choice due to the absence of potential secondary effects. Our study will try to optimize the utilization of hospital resources involved in the treatment of bronchiolitis. Infants suffering from this disease could therefore profit from better treatments which will be reflected in a better condition, life quality and consequently those of their parents.
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 |
|---|---|---|
| hypertonic saline solution | Active comparator | Drug: normal saline solutionHypertonic Saline 3% solution alone. |
| nebulized normal saline solution | Placebo comparator | Drug: normal saline solution2 nebulisation with 30 minute interval (max 4ml) |
Who may qualify
- Ages
- 6 weeks to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- clinical diagnosis of viral bronchiolitis
- Age 6 weeks to 12 months
- Clinical Score IRAS >3 and <8
Key exclusion criteria (7 listed)
- prematurity <30 weeks
- younger than 6 weeks of age
- chronic lung disease
- immunosuppression.
- History of wheezing or asthma.
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 |
|---|---|---|
| normal saline solutionAlso: Physiologic saline solutionTwo 4ml nebulizations with 30 minute interval | Drug | hypertonic saline solution, nebulized normal saline solution |
Primary outcome
Hospitalization Rate
Time frame: After 48 hours of treatment in the emergency department
1 secondary outcome
The IRAS (Infant Respiratory Assessment Score) will be measured after each Treatment to verify improvement.
Time frame: 30 minutes after each nebulization
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 7 Sep 2015.
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Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV in Children Under 6 Months in Bogotá
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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.
Guimont Chantal, MD, PhD. principal investigator
Laval University Hospital Center, Quebec, Canada.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal saline solution in people with Acute Viral Bronchiolitis., run by Laval University at 1 site 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 3 inclusion and 7 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 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Hospitalization Rate (time frame: After 48 hours of treatment in the emergency department). 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 7 Sep 2015.