Clinical trial NCT01814293: Comparison of Supportive Therapies for Symptom Relief From Pediatric Upper Respiratory Infections (URIs)
Official title: Comparison of Supportive Therapies for Symptom Relief From Pediatric Upper Respiratory Infections (URIs)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Upper Respiratory Infection
Signs and Symptoms
Keywords: Pediatric
Upper Respiratory infection
Over the Counter Drugs
Drugs, Non-Prescription
Vaporizer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Vapore, LLC
First posted: 2013-03-19
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility 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.

Primary outcomes:
measure: URI (upper respiratory infection) symptoms one day after ED visit
timeFrame: 1 day
measure: URI (upper respiratory infection) symptoms 2 days after ED visit
timeFrame: 1 day
Secondary outcomes:
measure: URI (upper respiratory infection) revisits
timeFrame: 2 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jacqueline A Nemer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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