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

This study has been terminated.
(loss of funding. No data was collected.)
Sponsor:
Collaborator:
Vapore, LLC
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01814293
First received: March 13, 2013
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Acute Upper Respiratory Infection
Signs and Symptoms
Device: Handheld humidifier

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comparison of Supportive Therapies for Symptom Relief From Pediatric Upper Respiratory Infections (URIs)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • URI (upper respiratory infection) symptoms one day after ED visit [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • URI (upper respiratory infection) revisits [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 2
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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).

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01814293

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Vapore, LLC
Investigators
Principal Investigator: Jacqueline A Nemer, MD University of California, San Francisco
  More Information

Additional Information:
Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01814293     History of Changes
Other Study ID Numbers: 12-10271
Study First Received: March 13, 2013
Last Updated: September 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Pediatric
Upper Respiratory infection
Over the Counter Drugs
Drugs, Non-Prescription
Vaporizer

Additional relevant MeSH terms:
Respiratory Tract Infections
Signs and Symptoms
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014