Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288857
• Other study ID #: 2017-06-0086
• Status: Completed
• Phase: N/A
• Start date: November 22, 2017
• Est. completion date: March 21, 2019

Study information

• Verified date: April 2019
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: March 21, 2019
• Est. primary completion date: March 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Aspirator
• Bronchiolitis

Intervention

Device:
• NeilMed Naspira
NeilMed Naspira is a nasal-oral aspirator

Locations

Country	Name	City	State
United States	Dell Children's Medical Center of Central Texas	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	Dell Children’s Medical Center of Central Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unscheduled bronchiolitis return visits	The number of unscheduled bronchiolitis return visits (return to either ED, urgent care or PCP)	14 days
Secondary	Oral intake	Effects of device on oral intake as determined by diary and post-study questionnaire	14 days
Secondary	Respiratory relief	Effects of device on respiratory relief as determined by diary and post-study questionnaire	14 days
Secondary	Parental device preference	Parental device preference as determined by diary and post-study questionnaire	14 days
Secondary	Adverse events	Description of adverse events as determined by diary and post-study questionnaire	14 days