BronchiolitisSNOTNCT03361371
Suctioning of NOse Therapy in Bronchiolitis
A study testing Battery operated nasal aspirator and Suction bulb in people with Bronchiolitis, run by The Hospital for Sick Children at 3 sites in Canada.
Trial summary
Research Questions: Primary: In otherwise healthy infants 4 weeks to 12 months of age discharged home from the ED with acute bronchiolitis,1 is there a difference in the probability of "treatment failure" by 72 hours post discharge from the index ED visit in those receiving nasal suctioning via Zo-Li device prior to… Read more about this study
- Who is it for?
- Ages 4 weeks to 12 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Battery operated nasal aspirator and Suction bulb
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 373 participants
- Where
- 3 sitesCanada
- Study dates
- 6 Mar 2020to 25 Jan 2023
- 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 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of bronchiolitis in the ED as per the AAP diagnosis definition. Bronchiolitis is defined as the first episode of viral upper respiratory infection with respiratory distress and/or tachypnea for age.
- Age 4 weeks up to and including 12 months of age. Participating infants will have to be at least 4 weeks post their expected due date of birth since infants with bronchiolitis below this age cut-off are at a much higher risk of apnea and dehydration than their older counterparts.
- Nasal congestion as per parental report and/or the treating physician
- Must have at least one of the following: home/cellular telephone or e- mail
- Informed consent
- Parent/Caregiver speaks English/French
Who cannot join
- Previous diagnosis of bronchiolitis made more than 3 weeks prior to this ED visit.
- Hospitalization at the index ED visit. Although we have considered starting the experimental intervention at presentation to the ED, this was deemed counterproductive since many patients with bronchiolitis are currently routinely suctioned in the ED which would likely contaminate the control arm and impact study results.
- Use of any battery operated suctioning device prior to arrival. These families may choose to continue these electrical devices which would contaminate the study groups.
- 4- Co-morbidities which may impact outcomes such as known diagnosis of congenital heart disease, chronic respiratory disease including known lung disease due to prematurity, aspiration due to severe gastro-esophageal reflux, neuro-muscular/neurologic disease, immunodeficiency, coagulopathies, nasal/upper airway abnormalities, oral, gastrointestinal anomalies [except for corrected pyloric stenosis], tracheo-esophageal fistulas, gastric/gastro-jejunal tube feeding supplementation.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
McMaster Children's Hospital
Hamilton, Ontario
London Children's Hospital
London, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario
About this study
Official title: Suctioning of NOse Therapy in Bronchiolitis - a Randomized Clinical Trial
Research Questions:
Primary:
Read more
In otherwise healthy infants 4 weeks to 12 months of age discharged home from the ED with acute bronchiolitis,1 is there a difference in the probability of "treatment failure" by 72 hours post discharge from the index ED visit in those receiving nasal suctioning via Zo-Li device prior to feeds compared to infants who receive nasal suctioning via bulb? Treatment failure is defined as 1) any bronchiolitis-related healthcare visit, except visits that have occurred only due to ED-recommendation at time of ED discharge or 2) the use of additional (non-study assigned) suctioning devices (see Outcome Measures section) within approximately 72 hours post discharge at the index ED visit.
Hypothesis:
We hypothesize that the infants who undergo scheduled nasal suctioning via ZoLi device will experience a lower treatment failure probability by approximately 72 hours post discharge from index ED visit compared to those managed by suction via a bulb.
Secondary:
- In these infants, is there a difference in the mean number of medical visits for bronchiolitis (defined as #1 under primary outcome above) within 72 hours of ED discharge?
- In these infants, is there a difference in the mean number of unscheduled medical visits for bronchiolitis within 72 hours of ED discharge?
- In these infants, is there a difference in the mean number of ED visits for bronchiolitis within 72 hours of ED discharge?
- In these infants, is there a difference in the probability of a parent reporting normal/near normal feeds on approximately 72 hours discharge?
- In these infants, is there a difference in the probability of a parent reporting normal/near normal sleeping on approximately 72 hours post ED discharge?
- For the parent, is there a difference in the probability of a parent reporting their own normal/near normal sleeping on approximately 72 hours post ED discharge?
- In these infants, is there a difference in the probability of parents reporting at 72 hours post ED discharge as being "very satisfied" or "satisfied" with their ability to care for their child during the study period?
The sample size calculation is based on the assessment of the between-group difference in probability of treatment failure. The estimated total re-visit probability in bronchiolitis based on a recently published study was approximately 35% within 72 hours of ED discharge.49 In our pilot we have found the same rate of treatment failure. This is a superiority study in which the adoption of nasal suctioning will be recommended for future practice if the observed proportion of the primary outcome in this group is significantly lower than in the controls. With 162 patients per arm (324 in total) a two-sided test with a type I error of 0.05 will have 80% power to achieve statistical significance if suctioning reduces the probability of treatment failure from 40% to 25% (i.e. absolute reduction of 15%). This estimate is based on clinically relevant differences agreed upon by study investigators and it also represents an NNT of 7. In the Cochrane review of asthma therapies an NNT of a comparable magnitude led to a change in national practice recommendations.51 Since bronchiolitis and related medical visits are highly prevalent,20 this target difference would also have an important economic impact. Based on our previous bronchiolitis trials, the anticipated refusal rate may be 20%. Given the study design and our past experience, the study non-completion rate and loss to follow-up can safely be assumed to be no higher than 5% each. Therefore, to have complete data on 324 patients we plan to randomize 360 (i.e. 324/ (1 - 0.05) *(1 - 0.05) and to approach 450 (i.e. 360/ (1 - 0.20).
Read the detailed description
This is a multi-center, randomized, outcome assessor- blinded clinical trial of infants discharged home from the ED with acute bronchiolitis. Two groups will be compared: infants receiving bronchiolitis suctioning via a bulb (see below) versus those given nasal suctioning via a battery-operated nasal aspiration Zo-Li device just prior to each feeding for 72 hours post index ED visit discharge. Evidence suggests that suctioning at frequent intervals is associated with movement of secretions from the lower airway with improved minute volume.40 The 72 hour study period has been chosen since the majority of infants discharged from the ED with bronchiolitis experience the targeted outcomes within this time frame.9
Prior to the ED discharge, all study participants will receive usual bronchiolitis care ordered by the ED physician as per standard of care which consists of supplemental oxygen for saturations <90% and supplemental IV hydration in those with inadequate oral intake.41 Eligible consenting patients deemed suitable for discharge home (representing approximately 60-70% of the bronchiolitis population presenting to the ED) will be randomly allocated to one of two study groups:
Control Group: this group will receive standardized routine discharge instructions describing information about bronchiolitis, expected course of illness, recommended management strategies such as fever control, augmented air humidification, need for frequent feeding and warning signs prompting return for care. This group will be suctioned prior to feeds via bulb suction (with saline drops) which is expected to provide minimal effect, due to non-sustained negative pressures generated during bulb release. Since the benefit of nasal suction in bronchiolitis is unknown, this design is ethically reasonable. However, the use of no suction would likely meet with parental resistance and enrollment would be difficult. Families in the control group will be given the bulb device at no cost and instructed in the appropriate technique of using this tool prior to feeds.
Intervention Group: in addition to receiving the aforementioned bronchiolitis discharge instructions, this group will undergo nasal suctioning prior to each feeding as needed for 72 hours post discharge home, using exclusively the Zo-Li study device (see above under study device), with saline nose drops. Families in this group will be given the Zo-Li device at no cost and instructed in the appropriate technique and importance of using this tool.
We shall not reveal the identity of the study devices to the ED physicians in order to minimize contamination of the control group. The ED treating physicians will also be blinded to which device the infant had been randomized to. We shall also ask the ED treating physicians not to recommend specific suctioning devices to the study patients.
- Conditions
- Bronchiolitis
- Being tested
- Battery operated nasal aspirator, Suction bulb
- Keywords
- Nose suctioning, Pediatric
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Battery operated nasal aspiratorDevice
Suctioning prior to every feed with battery operated nasal aspirator for three days in addition to the routine standard of care.
Suction bulbDevice
Suctioning prior to every feed with bulb nasal aspirator for three days in addition to the routine standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Intervention Group: in addition to receiving the aforementioned bronchiolitis discharge instructions, this group will undergo nasal suctioning prior to each feeding as needed for 72 hours post discharge home, using exclusively the Zo-Li study device (see above under study device), with saline nose drops. Families in this group will be given the Zo-Li device at no cost and instructed in the appropriate technique and importance of using this tool.
We shall not reveal the identity of the study devices to the ED physicians in order to minimize contamination of the control group. The ED treating physicians will also be blinded to which device the infant had been randomized to. We shall also ask the ED treating physicians not to recommend specific suctioning devices to the study patients. Receives: Device: Battery operated nasal aspirator |
| Control group | Placebo comparator | Control Group: this group will receive standardized routine discharge instructions describing information about bronchiolitis, expected course of illness, recommended management strategies such as fever control, augmented air humidification, need for frequent feeding and warning signs prompting return for care. This group will be suctioned prior to feeds via bulb suction (with saline drops) which is expected to provide minimal effect, due to non-sustained negative pressures generated during bulb release. Since the benefit of nasal suction in bronchiolitis is unknown, this design is ethically reasonable. However, the use of no suction would likely meet with parental resistance and enrollment would be difficult. Families in the control group will be given the bulb device at no cost and instructed in the appropriate technique of using this tool prior to feeds. Receives: Device: Suction bulb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure as measured by questionnaire administered on day 3
Occurrence of any of the following by day 3 post discharge home: Hospitalization for bronchiolitis, unscheduled medical visit, physician initiated visit for bronchiolitis within 3 days post discharge from initial ED visit
Measured: Within 3 days post ED discharge at index visit
Secondary outcomes (6)
Unscheduled, i.e. family-initiated return medical visit for bronchiolitis as measured by questionnaire administered on day 3
Family-initiated bronchiolitis-related medical visit
Measured: Within 3 days post ED discharge at index visit
Emergency Department re-visit as measured by questionnaire administered on day 3
ED visits for ongoing/worsening bronchiolitis symptoms
Measured: Within 3 days post ED discharge at index visit
Feeding adequacy as measured by questionnaire administered on day 3
Normal/near normal feeding
Measured: Within 3 days post ED discharge at index visit
Participant sleeping adequacy as measured by questionnaire administered on day 3
Normal/near normal sleeping pattern
Measured: Within 3 days post ED discharge at index visit
Parental sleeping adequacy as measured by questionnaire administered on day 3
Normal/near normal sleeping pattern
Measured: Within 3 days post ED discharge at index visit
Parental ability to care for their sick child as measured by questionnaire administered on day 3
Parental level of satisfaction for their ability to care for their child's illness
Measured: Within 3 days post ED discharge at index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start6 Mar 2020
- Primary completion30 Dec 2022
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Model description
- Prospective interventional.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, Children's Hospital of Eastern Ontario, London Health Sciences Centre, McMaster University
- Responsible party
- Principal investigator, Suzanne Schuh, The Hospital for Sick Children
- Investigators
- Suzanne Schuh, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361371
- Sponsor's protocol ID
- 1671
- Acronym
- SNOT
- Status last verified
- Feb 2023
- First submitted
- 21 Nov 2017
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Schuh S, Coates AL, Sweeney J, Rumantir M, Eltorki M, Alqurashi W, Plint AC, Zemek R, Poonai N, Parkin PC, Soares D, Moineddin R, Finkelstein Y; Pediatric Emergency Research Canada (PERC) Network. Nasal Suctioning Therapy Among Infants With Bronchiolitis Discharged Home From the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2337810. doi: 10.1001/jamanetworkopen.2023.37810.
PubMed 37856126
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suctioning of NOse Therapy in Bronchiolitis - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03361371
- Acronym / sponsor ID
- SNOT / 1671
- Conditions
- Bronchiolitis
- Keywords
- Nose suctioning, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, Children's Hospital of Eastern Ontario, London Health Sciences Centre, McMaster University
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 4 Dec 2017 (actual)
- 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.
Research Questions:
Primary:
In otherwise healthy infants 4 weeks to 12 months of age discharged home from the ED with acute bronchiolitis,1 is there a difference in the probability of "treatment failure" by 72 hours post discharge from the index ED visit in those receiving nasal suctioning via Zo-Li device prior to feeds compared to infants who receive nasal suctioning via bulb? Treatment failure is defined as 1) any bronchiolitis-related healthcare visit, except visits that have occurred only due to ED-recommendation at time of ED discharge or 2) the use of additional (non-study assigned) suctioning devices (see Outcome Measures section) within approximately 72 hours post discharge at the index ED visit.
Hypothesis:
We hypothesize that the infants who undergo scheduled nasal suctioning via ZoLi device will experience a lower treatment failure probability by approximately 72 hours post discharge from index ED visit compared to those managed by suction via a bulb.
Secondary:
- In these infants, is there a difference in the mean number of medical visits for bronchiolitis (defined as #1 under primary outcome above) within 72 hours of ED discharge?
- In these infants, is there a difference in the mean number of unscheduled medical visits for bronchiolitis within 72 hours of ED discharge?
- In these infants, is there a difference in the mean number of ED visits for bronchiolitis within 72 hours of ED discharge?
- In these infants, is there a difference in the probability of a parent reporting normal/near normal feeds on approximately 72 hours discharge?
- In these infants, is there a difference in the probability of a parent reporting normal/near normal sleeping on approximately 72 hours post ED discharge?
- For the parent, is there a difference in the probability of a parent reporting their own normal/near normal sleeping on approximately 72 hours post ED discharge?
- In these infants, is there a difference in the probability of parents reporting at 72 hours post ED discharge as being "very satisfied" or "satisfied" with their ability to care for their child during the study period?
The sample size calculation is based on the assessment of the between-group difference in probability of treatment failure. The estimated total re-visit probability in bronchiolitis based on a recently published study was approximately 35% within 72 hours of ED discharge.49 In our pilot we have found the same rate of treatment failure. This is a superiority study in which the adoption of nasal suctioning will be recommended for future practice if the observed proportion of the primary outcome in this group is significantly lower than in the controls. With 162 patients per arm (324 in total) a two-sided test with a type I error of 0.05 will have 80% power to achieve statistical significance if suctioning reduces the probability of treatment failure from 40% to 25% (i.e. absolute reduction of 15%). This estimate is based on clinically relevant differences agreed upon by study investigators and it also represents an NNT of 7. In the Cochrane review of asthma therapies an NNT of a comparable magnitude led to a change in national practice recommendations.51 Since bronchiolitis and related medical visits are highly prevalent,20 this target difference would also have an important economic impact. Based on our previous bronchiolitis trials, the anticipated refusal rate may be 20%. Given the study design and our past experience, the study non-completion rate and loss to follow-up can safely be assumed to be no higher than 5% each. Therefore, to have complete data on 324 patients we plan to randomize 360 (i.e. 324/ (1 - 0.05) *(1 - 0.05) and to approach 450 (i.e. 360/ (1 - 0.20).
Detailed description
This is a multi-center, randomized, outcome assessor- blinded clinical trial of infants discharged home from the ED with acute bronchiolitis. Two groups will be compared: infants receiving bronchiolitis suctioning via a bulb (see below) versus those given nasal suctioning via a battery-operated nasal aspiration Zo-Li device just prior to each feeding for 72 hours post index ED visit discharge. Evidence suggests that suctioning at frequent intervals is associated with movement of secretions from the lower airway with improved minute volume.40 The 72 hour study period has been chosen since the majority of infants discharged from the ED with bronchiolitis experience the targeted outcomes within this time frame.9
Prior to the ED discharge, all study participants will receive usual bronchiolitis care ordered by the ED physician as per standard of care which consists of supplemental oxygen for saturations <90% and supplemental IV hydration in those with inadequate oral intake.41 Eligible consenting patients deemed suitable for discharge home (representing approximately 60-70% of the bronchiolitis population presenting to the ED) will be randomly allocated to one of two study groups:
Control Group: this group will receive standardized routine discharge instructions describing information about bronchiolitis, expected course of illness, recommended management strategies such as fever control, augmented air humidification, need for frequent feeding and warning signs prompting return for care. This group will be suctioned prior to feeds via bulb suction (with saline drops) which is expected to provide minimal effect, due to non-sustained negative pressures generated during bulb release. Since the benefit of nasal suction in bronchiolitis is unknown, this design is ethically reasonable. However, the use of no suction would likely meet with parental resistance and enrollment would be difficult. Families in the control group will be given the bulb device at no cost and instructed in the appropriate technique of using this tool prior to feeds.
Intervention Group: in addition to receiving the aforementioned bronchiolitis discharge instructions, this group will undergo nasal suctioning prior to each feeding as needed for 72 hours post discharge home, using exclusively the Zo-Li study device (see above under study device), with saline nose drops. Families in this group will be given the Zo-Li device at no cost and instructed in the appropriate technique and importance of using this tool.
We shall not reveal the identity of the study devices to the ED physicians in order to minimize contamination of the control group. The ED treating physicians will also be blinded to which device the infant had been randomized to. We shall also ask the ED treating physicians not to recommend specific suctioning devices to the study patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective interventional.
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Device: Battery operated nasal aspiratorIntervention Group: in addition to receiving the aforementioned bronchiolitis discharge instructions, this group will undergo nasal suctioning prior to each feeding as needed for 72 hours post discharge home, using exclusively the Zo-Li study device (see above under study device), with saline nose drops. Families in this group will be given the Zo-Li device at no cost and instructed in the appropriate technique and importance of using this tool. We shall not reveal the identity of the study devices to the ED physicians in order to minimize contamination of the control group. The ED treating physicians will also be blinded to which device the infant had been randomized to. We shall also ask the ED treating physicians not to recommend specific suctioning devices to the study patients. |
| Control group | Placebo comparator | Device: Suction bulbControl Group: this group will receive standardized routine discharge instructions describing information about bronchiolitis, expected course of illness, recommended management strategies such as fever control, augmented air humidification, need for frequent feeding and warning signs prompting return for care. This group will be suctioned prior to feeds via bulb suction (with saline drops) which is expected to provide minimal effect, due to non-sustained negative pressures generated during bulb release. Since the benefit of nasal suction in bronchiolitis is unknown, this design is ethically reasonable. However, the use of no suction would likely meet with parental resistance and enrollment would be difficult. Families in the control group will be given the bulb device at no cost and instructed in the appropriate technique of using this tool prior to feeds. |
Who may qualify
- Ages
- 4 weeks to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosis of bronchiolitis in the ED as per the AAP diagnosis definition. Bronchiolitis is defined as the first episode of viral upper respiratory infection with respiratory distress and/or tachypnea for age.
- Age 4 weeks up to and including 12 months of age. Participating infants will have to be at least 4 weeks post their expected due date of birth since infants with bronchiolitis below this age cut-off are at a much higher risk of apnea and dehydration than their older counterparts.
- Nasal congestion as per parental report and/or the treating physician
- Must have at least one of the following: home/cellular telephone or e- mail
- Informed consent
Key exclusion criteria (4 listed)
- Previous diagnosis of bronchiolitis made more than 3 weeks prior to this ED visit.
- Hospitalization at the index ED visit. Although we have considered starting the experimental intervention at presentation to the ED, this was deemed counterproductive since many patients with bronchiolitis are currently routinely suctioned in the ED which would likely contaminate the control arm and impact study results.
- Use of any battery operated suctioning device prior to arrival. These families may choose to continue these electrical devices which would contaminate the study groups.
- 4- Co-morbidities which may impact outcomes such as known diagnosis of congenital heart disease, chronic respiratory disease including known lung disease due to prematurity, aspiration due to severe gastro-esophageal reflux, neuro-muscular/neurologic disease, immunodeficiency, coagulopathies, nasal/upper airway abnormalities, oral, gastrointestinal anomalies [except for corrected pyloric stenosis], tracheo-esophageal fistulas, gastric/gastro-jejunal tube feeding supplementation.
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 |
|---|---|---|
| Battery operated nasal aspiratorSuctioning prior to every feed with battery operated nasal aspirator for three days in addition to the routine standard of care. | Device | Interventional group |
| Suction bulbSuctioning prior to every feed with bulb nasal aspirator for three days in addition to the routine standard of care. | Device | Control group |
Primary outcome
Treatment failure as measured by questionnaire administered on day 3
Time frame: Within 3 days post ED discharge at index visit
Occurrence of any of the following by day 3 post discharge home: Hospitalization for bronchiolitis, unscheduled medical visit, physician initiated visit for bronchiolitis within 3 days post discharge from initial ED visit
6 secondary outcomes
Unscheduled, i.e. family-initiated return medical visit for bronchiolitis as measured by questionnaire administered on day 3
Time frame: Within 3 days post ED discharge at index visit
Emergency Department re-visit as measured by questionnaire administered on day 3
Time frame: Within 3 days post ED discharge at index visit
Feeding adequacy as measured by questionnaire administered on day 3
Time frame: Within 3 days post ED discharge at index visit
Participant sleeping adequacy as measured by questionnaire administered on day 3
Time frame: Within 3 days post ED discharge at index visit
Parental sleeping adequacy as measured by questionnaire administered on day 3
Time frame: Within 3 days post ED discharge at index visit
Parental ability to care for their sick child as measured by questionnaire administered on day 3
Time frame: Within 3 days post ED discharge at index visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 37856126Schuh S, Coates AL, Sweeney J, Rumantir M, Eltorki M, Alqurashi W, Plint AC, Zemek R, Poonai N, Parkin PC, Soares D, Moineddin R, Finkelstein Y; Pediatric Emergency Research Canada (PERC) Network. Nasal Suctioning Therapy Among Infants With Bronchiolitis Discharged Home From the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2337810. doi: 10.1001/jamanetworkopen.2023.37810.
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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.
Suzanne Schuh, MD principal investigator
The Hospital for Sick Children
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Battery operated nasal aspirator and Suction bulb in people with Bronchiolitis, run by The Hospital for Sick Children 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 8 Feb 2023. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment failure as measured by questionnaire administered on day 3 (time frame: Within 3 days post ED discharge at index visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03361371, which also lists 1 linked publication.
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 8 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.