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

NCT ID: NCT03288857

Last Updated: 2019-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-22
• Study Completion Date: 2019-03-21

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.

Conditions

Bronchiolitis; Aspirator

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bulb Aspirator

If randomized to the bulb aspirator group, the patient will be sent home with a bulb aspirator to use for home nasal secretion management

Group Type: NO_INTERVENTION

No interventions assigned to this group

Nasal Oral Aspirator (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

Group Type: EXPERIMENTAL

NeilMed Naspira

Intervention Type: DEVICE

NeilMed Naspira is a nasal-oral aspirator

Interventions

NeilMed Naspira

NeilMed Naspira is a nasal-oral aspirator

Intervention Type: DEVICE

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dell Children's Medical Center of Central Texas

OTHER

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Whitney Schwarz

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35100758 (View on PubMed)

Other Identifiers

2017-06-0086

Identifier Type: -

Identifier Source: org_study_id