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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01814293
Recruitment Status : Withdrawn (loss of funding. No data was collected.)
First Posted : March 19, 2013
Last Update Posted : May 15, 2015
Sponsor:
Collaborator:
Vapore, LLC
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE March 13, 2013
First Posted Date  ICMJE March 19, 2013
Last Update Posted Date May 15, 2015
Study Start Date  ICMJE May 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2013)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01814293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Supportive Therapies for Symptom Relief From Pediatric Upper Respiratory Infections (URIs)
Official Title  ICMJE Comparison of Supportive Therapies for Symptom Relief From Pediatric Upper Respiratory Infections (URIs)
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Acute Upper Respiratory Infection
  • Signs and Symptoms
Intervention  ICMJE 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 Name: MyPurMist (specific handheld humidifier used in this trial)
Study Arms  ICMJE
  • 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.
    Intervention: Device: Handheld humidifier
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 13, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2013)
150
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01814293
Other Study ID Numbers  ICMJE 12-10271
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Vapore, LLC
Investigators  ICMJE
Principal Investigator: Jacqueline A Nemer, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP