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

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.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis; Aspirator
• Intervention / Treatment: Device: NeilMed Naspira

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 Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Center of Central Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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
Experimental: 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	Device: NeilMed Naspira; NeilMed Naspira is a nasal-oral aspirator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unscheduled bronchiolitis return visits	The number of unscheduled bronchiolitis return visits (return to either ED, urgent care or PCP)	14 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: Dell Children's Medical Center of Central Texas

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Actual): March 21, 2019
• Study Completion (Actual): March 21, 2019

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Children; Suctioning; Naspira; Nasal suction device
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 2017-06-0086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No