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

Not Applicable

Completed

• Conditions: Bronchiolitis; Aspirator
• Interventions: Device: NeilMed Naspira

• Registration Number: NCT03288857
• Lead Sponsor: University of Texas at Austin

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.

Study Timeline

• Study First Submitted: 2017-09-13
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-20
• Study Start: 2017-11-22
• Primary Completion: 2019-03-21
• Study Completion: 2019-03-21
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-18
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal Oral Aspirator (NeilMed Naspira)	NeilMed Naspira	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

Primary Outcome Measures

Name	Time	Method
Unscheduled bronchiolitis return visits	14 days	The number of unscheduled bronchiolitis return visits (return to either ED, urgent care or PCP)

Secondary Outcome Measures

Name	Time	Method
Oral intake	14 days	Effects of device on oral intake as determined by diary and post-study questionnaire
Respiratory relief	14 days	Effects of device on respiratory relief as determined by diary and post-study questionnaire
Parental device preference	14 days	Parental device preference as determined by diary and post-study questionnaire
Adverse events	14 days	Description of adverse events as determined by diary and post-study questionnaire

Trial Locations

Locations (1)

Dell Children's Medical Center of Central Texas; 🇺🇸 Austin, Texas, United States