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Battery operated nasal aspirator for Bronchiolitis (SNOT Trial)

N/A

Waitlist Available

Led By Suzanne Schuh, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 3 days post ed discharge at index visit

Awards & highlights

SNOT Trial Summary

This trial is testing whether using a Zo-Li device to suction an infant's nose before feeds, compared to using a bulb, decreases the probability of "treatment failure" within 72 hours of discharge from the ED for infants with acute bronchiolitis. 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. The trial will enroll 450 infants and will follow them for 72 hours after ED discharge.

SNOT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 3 days post ed discharge at index visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 3 days post ed discharge at index visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 days post ed discharge at index visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment failure as measured by questionnaire administered on day 3

Secondary outcome measures

Emergency Department re-visit as measured by questionnaire administered on day 3

Feeding adequacy as measured by questionnaire administered on day 3

Parental ability to care for their sick child as measured by questionnaire administered on day 3

+3 more

Other outcome measures

Clinically important side-effects from nasal suctioning as measured by questionnaire administered on day 3

SNOT Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Interventional groupExperimental Treatment1 Intervention

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.

Group II: Control groupPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Battery operated nasal aspirator

2020

N/A

~380

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Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

691 Previous Clinical Trials

6,945,241 Total Patients Enrolled

7 Trials studying Bronchiolitis

1,764 Patients Enrolled for Bronchiolitis

The Physicians' Services Incorporated FoundationOTHER

162 Previous Clinical Trials

26,382 Total Patients Enrolled

1 Trials studying Bronchiolitis

120 Patients Enrolled for Bronchiolitis

Children's Hospital of Eastern OntarioOTHER

126 Previous Clinical Trials

55,109 Total Patients Enrolled

2 Trials studying Bronchiolitis

1,083 Patients Enrolled for Bronchiolitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly participants being included in the experiment?

"This medical trial is only available for infants aged between 4 weeks and 12 months. Additionally, there are 24 studies for minors under 18 years old and a further 18 dedicated to those above 65."

Answered by AI

Is this clinical trial currently recruiting participants?

"Affirmative. The clinicaltrials.gov website reveals that this trial is actively seeking participants, with a total of 412 patients being required from 3 different locations. This study was originally published on March 6th 2020 and was recently updated as of June 7th 2022."

Answered by AI

Who fulfills the criteria to take part in this investigation?

"Qualified applicants must have bronchiolitis and be between 4 weeks old and 12 months of age. This clinical trial is aiming to recruit a total of 412 participants."

Answered by AI

How many individuals are being administered the experimental treatment in this clinical research?

"Affirmative. According to clinicaltrials.gov, the trial which was initially published on March 6th 2020 is still currently recruiting 412 participants from 3 sites. It has been edited most recently on June 7th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Suctioning of NOse Therapy in Bronchiolitis

Suzanne Schuh 2020. "Suctioning of NOse Therapy in Bronchiolitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03361371.