Comparison of Supportive Therapies for Symptom Relief From Pediatric Upper Respiratory Infections (URIs)

May 13, 2015 updated by: University of California, San Francisco
This is a nonblinded randomized controlled trial which is a survey-based comparison between supportive treatments for symptom relief from pediatric upper respiratory infection (URI). The primary objective of this study is to determine if the use of handheld humidifier improves URI symptom scores and/or reduces use of over the counter medications compared to other supportive treatments for pediatric URIs (ie. OTC cold medications, room air humidifier). Study duration is approximately 1 year and the individual intervention is 4 days.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Study design is a nonblinded randomized controlled trial. It is a survey-based comparison study of pediatric patients presenting to the Emergency Department (ED) with upper respiratory infection (URI) symptoms for which the ED physician has recommended supportive care only (ie. non-prescription symptom relief). Study duration is approximately one year. Subject participation duration is 4 days.

Subjects will be randomized into 2 groups: handheld humidifier group (FDA cleared medical device that uses distilled water) & control group. Both groups may use any supportive modalities desired such as over-the-counter cold medications (OTCs), room air humidifier etc.

Primary study objective is to determine if the use of handheld humidifier improves URI symptom scores (nocturnal cough, parental perception) and/or reduces use of other supportive modalities compared to the control group for the relief of pediatric URI symptoms.

Three surveys will be obtained from all subjects. The initial survey occurs at the time of enrollment (T0). The second and third surveys will be completed by the parent/guardian on line or by phone on the first day after ED visit (T-1) and sometime between the 2nd-4th day after ED visit (T-2). The survey component includes a validated pediatric cough questionnaire with 7 point Likert scale, and a questions regarding any other supportive treatments used for symptom relief (the type, frequency and results).

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 0-18 years old
  • URI symptoms of less than 1 week duration.
  • No new medications prescribed during this ED visit other than antipyretics and refills of routine medications (ie. refills of bronchodilators are OK).
  • Symptom severity scores of atleast 3 ("sometimes" on a Likert 7 point scale) on at least 2 survey questions related to symptom scores (cough frequency/severity, effect on the child's sleep, effect on parental sleep, combined symptom severity).
  • Parent consenting the child must have two valid forms of contact information (ie. phone number and email address) in order to follow up as needed for completion of 2nd and 3rd surveys.
  • Parent consenting the child must have access to internet connection or phone for the following 2-4 days after enrollment.
  • Parent consenting the child must be able to fluently read and speak English without the use of aides. This study budget does not allow for multilingual resources.

Exclusion Criteria:

  • Chronic pulmonary disease
  • Chronic or congenital cardiac disease
  • Chronic cough
  • Acute pneumonia
  • Any patient that will receive a new prescription from this ED visit (antibiotics, inhalers, steroids, etc)
  • Any patient currently using a handheld humidifier for this URI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Handheld humidifier
Study design is a nonblinded randomized controlled comparison study of pediatric patients presenting to the UCSF Emergency Department (ED) with upper respiratory infection (URI) symptoms for which the ED physician has recommended supportive care only (ie. non-prescription symptom relief). Subjects will be randomized into 2 groups: handheld humidifier group (FDA cleared medical device that uses distilled water) & control group. Both groups may use any supportive modalities desired such as over-the-counter cold medications (OTCs), room air humidifier etc. Follow up surveys will be obtained on days 1 and 2 following the ED visit to assess whether then intervention (use of handheld humidifier) improved symptom scores or reduced the use of OTC medications or room humidifier.
Device: Handheld humidifier
Subjects will be randomized into 2 groups: handheld humidifier group (FDA cleared medical device that uses distilled water) & control group. Both groups may use any supportive modalities desired such as over-the-counter cold medications (OTCs), room air humidifier etc. Follow up surveys will be obtained on days 1 and 2 following the ED visit to assess whether then intervention (use of handheld humidifier) improved symptom scores or reduced the use of OTC medications or room humidifier.
Other Names:
  • MyPurMist (specific handheld humidifier used in this trial)
No Intervention: Control group
Subjects will manage cold symptoms with any desired supportive over the counter treatment, and complete surveys related to symptom scores and modalities used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
URI (upper respiratory infection) symptoms one day after ED visit
Time Frame: 1 day
Differences in symptom scores will be compared between handheld humidifier group and control group based on supportive treatments used. Proposed outcome is that the humidifier group has improved symptom scores and/or reduced use of other supportive modalities (ie. cold meds) compared to the control group during the time frame between the ED visit to the following day.
1 day
URI (upper respiratory infection) symptoms 2 days after ED visit
Time Frame: 1 day
Differences in symptom scores will be compared between handheld humidifier group and control group based on supportive treatments used. Proposed outcome is that the humidifier group has improved symptom scores and/or reduced use of other supportive modalities (ie. cold meds) compared to the control group during the time frame between the 1st and 2nd days following the ED visit.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
URI (upper respiratory infection) revisits
Time Frame: 2 days
Comparison between handheld humidifier group and control group regarding each group's symptom scores and need for revisits for same URI. Potential additional findings may include reduction of revisits for same URI, parental observed reduction in severity and/or duration of illness.
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Vapore, LLC

Investigators

  • Principal Investigator: Jacqueline A Nemer, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

March 15, 2013

First Posted (Estimate)

March 19, 2013

Study Record Updates

Last Update Posted (Estimate)

May 15, 2015

Last Update Submitted That Met QC Criteria

May 13, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-10271

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Upper Respiratory Infection

Clinical Trials on Handheld humidifier

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe