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OpenTrials
Completed

NCT Number: NCT03288857

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.

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Key information

Conditions

Bronchiolitis Aspirator Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeilMed Naspira

Device

NeilMed Naspira is a nasal-oral aspirator

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Dell Children's Medical Center of Central Texas

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 20, 2017
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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