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

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ClinicalTrials.gov Identifier: NCT03288857
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : November 29, 2017
Sponsor:
Collaborator:
Dell Children’s Medical Center of Central Texas
Information provided by (Responsible Party):
Whitney Schwarz, 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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Aspirator Device: NeilMed Naspira Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

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




Primary Outcome Measures :
  1. Unscheduled bronchiolitis return visits [ Time Frame: 14 days ]
    The number of unscheduled bronchiolitis return visits (return to either ED, urgent care or PCP)


Secondary Outcome Measures :
  1. Oral intake [ Time Frame: 14 days ]
    Effects of device on oral intake as determined by diary and post-study questionnaire

  2. Respiratory relief [ Time Frame: 14 days ]
    Effects of device on respiratory relief as determined by diary and post-study questionnaire

  3. Parental device preference [ Time Frame: 14 days ]
    Parental device preference as determined by diary and post-study questionnaire

  4. Adverse events [ Time Frame: 14 days ]
    Description of adverse events as determined by diary and post-study questionnaire



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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288857


Contacts
Contact: Whitney W Schwarz, MD 5126324596 wwroe87@gmail.com
Contact: Matthew Wilkinson, MD 512452-8533 MHWilkinson@ascension.org

Locations
United States, Texas
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Whitney W Schwarz, MD    512-632-4596    wwroe87@gmail.com   
Contact: Wilkinson Matthew, MD       mhwilkinson@ascension.org   
Sponsors and Collaborators
University of Texas at Austin
Dell Children’s Medical Center of Central Texas

Responsible Party: Whitney Schwarz, Principle Investigator, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03288857     History of Changes
Other Study ID Numbers: 2017-06-0086
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Whitney Schwarz, University of Texas at Austin:
Naspira
Suctioning
Nasal suction device
Children

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections