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

The University of Texas System (UT)

Status: Completed

Conditions: Bronchiolitis; Aspirator

Treatments: Device: NeilMed Naspira

Study type: Interventional

Funder types: Other

Identifiers

NCT03288857

2017-06-0086

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 patients

Sex: All

Ages: 1 to 24 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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236 participants in 2 patient groups

Bulb Aspirator

No Intervention group

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

Nasal Oral Aspirator (NeilMed Naspira)

Experimental group

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

Treatment:

Device: NeilMed Naspira