NCT03288857

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 1 Month – 24 Months
• Healthy volunteers: Accepted

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.

Conditions

• Bronchiolitis
• Aspirator

Interventions

Type	Name	Description
DEVICE	NeilMed Naspira	NeilMed Naspira is a nasal-oral aspirator

Timeline

• Start date: 2017-11-22
• Primary completion: 2019-03-21
• Completion: 2019-03-21
• First posted: 2017-09-20
• Last updated: 2019-04-19

Locations

1 site across 1 country: United States