Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis
Primary Purpose
Bronchiolitis, Aspirator
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeilMed Naspira
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Naspira, Suctioning, Nasal suction device, Children
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Dell Children's Medical Center of Central Texas
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Bulb Aspirator
Nasal Oral Aspirator (NeilMed Naspira)
Arm Description
If randomized to the bulb aspirator group, the patient will be sent home with a bulb aspirator to use for home nasal secretion management
If randomized to the nasal oral aspirator group, patient will be sent home with a nasal oral aspirator to use for home nasal secretion management
Outcomes
Primary Outcome Measures
Unscheduled bronchiolitis return visits
The number of unscheduled bronchiolitis return visits (return to either ED, urgent care or PCP)
Secondary Outcome Measures
Oral intake
Effects of device on oral intake as determined by diary and post-study questionnaire
Respiratory relief
Effects of device on respiratory relief as determined by diary and post-study questionnaire
Parental device preference
Parental device preference as determined by diary and post-study questionnaire
Adverse events
Description of adverse events as determined by diary and post-study questionnaire
Full Information
NCT ID
NCT03288857
First Posted
September 13, 2017
Last Updated
April 18, 2019
Sponsor
University of Texas at Austin
Collaborators
Dell Children's Medical Center of Central Texas
1. Study Identification
Unique Protocol Identification Number
NCT03288857
Brief Title
Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis
Official Title
Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 22, 2017 (Actual)
Primary Completion Date
March 21, 2019 (Actual)
Study Completion Date
March 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
Dell Children's Medical Center of Central Texas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This study will be a single center, single blind, randomized controlled trial in the pediatric emergency department (ED) at Dell Children's Medical Center of Central Texas (DCMC). An ED discharge diagnosis of bronchiolitis will trigger patients to be randomized to receive a bulb aspirator or nasal oral aspirator for home secretion management use. Prior to dispensing the randomized aspirator, a pre-distribution questionnaire will be administered. Additionally, patients will receive a diary to complete for 3 days post ED discharge. Research personnel will call families on day 4 as a reminder to return the diary and again on day 14 to obtain a verbal post-study questionnaire. Research personnel will perform chart review on all patients looking for unscheduled patient return visits for bronchiolitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Aspirator
Keywords
Naspira, Suctioning, Nasal suction device, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
236 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bulb Aspirator
Arm Type
No Intervention
Arm Description
If randomized to the bulb aspirator group, the patient will be sent home with a bulb aspirator to use for home nasal secretion management
Arm Title
Nasal Oral Aspirator (NeilMed Naspira)
Arm Type
Experimental
Arm Description
If randomized to the nasal oral aspirator group, patient will be sent home with a nasal oral aspirator to use for home nasal secretion management
Intervention Type
Device
Intervention Name(s)
NeilMed Naspira
Intervention Description
NeilMed Naspira is a nasal-oral aspirator
Primary Outcome Measure Information:
Title
Unscheduled bronchiolitis return visits
Description
The number of unscheduled bronchiolitis return visits (return to either ED, urgent care or PCP)
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Oral intake
Description
Effects of device on oral intake as determined by diary and post-study questionnaire
Time Frame
14 days
Title
Respiratory relief
Description
Effects of device on respiratory relief as determined by diary and post-study questionnaire
Time Frame
14 days
Title
Parental device preference
Description
Parental device preference as determined by diary and post-study questionnaire
Time Frame
14 days
Title
Adverse events
Description
Description of adverse events as determined by diary and post-study questionnaire
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Dell Children's Medical Center of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35100758
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis
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