Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis
1 other identifier
interventional
236
1 country
1
Brief Summary
The investigators aim to compare the standard bulb aspirator with that of a nasal oral aspirator. The hypothesis is that use of a nasal oral aspirator is more effective at removing nasal secretions in the treatment of bronchiolitis as measured by a predicted 50% decrease in the rate of unscheduled bronchiolitis return visits. The primary endpoint will be the number of unscheduled bronchiolitis return visits; secondary endpoints will include measurements of oral intake, respiratory relief, parental device preference and adverse events.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
1 active site
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
First Submitted
Initial submission to the registry
September 13, 2017
CompletedFirst Posted
Study publicly available on registry
September 20, 2017
CompletedStudy Start
First participant enrolled
November 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2019
CompletedApril 19, 2019
April 1, 2019
1.3 years
September 13, 2017
April 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Unscheduled bronchiolitis return visits
The number of unscheduled bronchiolitis return visits (return to either ED, urgent care or PCP)
14 days
Secondary Outcomes (4)
Oral intake
14 days
Respiratory relief
14 days
Parental device preference
14 days
Adverse events
14 days
Study Arms (2)
Bulb Aspirator
NO INTERVENTIONIf randomized to the bulb aspirator group, the patient will be sent home with a bulb aspirator to use for home nasal secretion management
Nasal Oral Aspirator (NeilMed Naspira)
EXPERIMENTALIf randomized to the nasal oral aspirator group, patient will be sent home with a nasal oral aspirator to use for home nasal secretion management
Interventions
NeilMed Naspira is a nasal-oral aspirator
Eligibility Criteria
You may qualify if:
- Children \>28 days of life to \< 2 years of age discharged home from the DCMC ED with a diagnosis of bronchiolitis (diagnosis made per provider discretion)
- Caregiver fluent in English or Spanish
You may not qualify if:
- Previous enrollment
- Hospital admission
- Parental refusal to be randomized to an aspirator device (i.e., family prefers current device and does not wish to be randomized to a potentially different product)
- Current bacterial pneumonia
- Diagnosis of asthma
- Chronic lung disease
- Significant underlying cardiac disease
- Chronic neuromuscular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
Related Publications (1)
Schwarz WW, Wilkinson M, Allen A. Randomized Controlled Trial Comparing the Bulb Aspirator With a Nasal-Oral Aspirator in the Treatment of Bronchiolitis. Pediatr Emerg Care. 2022 Feb 1;38(2):e529-e533. doi: 10.1097/PEC.0000000000002372.
PMID: 35100758DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
September 13, 2017
First Posted
September 20, 2017
Study Start
November 22, 2017
Primary Completion
March 21, 2019
Study Completion
March 21, 2019
Last Updated
April 19, 2019
Record last verified: 2019-04