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

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv) Infection

Common Cold (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01814293

12-10271

Ages < 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 refillsof routine medications (ie. refills of bronchodilators are OK).
Symptom severity scores of atleast 3 ("sometimes" on a Likert 7 point scale) on atleast 2 survey questions related to symptom scores (cough frequency/severity, effecton 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 2ndand 3rd surveys.
Parent consenting the child must have access to internet connection or phone for thefollowing 2-4 days after enrollment.
Parent consenting the child must be able to fluently read and speak English withoutthe use of aides. This study budget does not allow for multilingual resources.

Exclusion

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 Design

May 01, 2013

September 30, 2013

Study 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).

Connect with a study center

University of California San Francisco
San Francisco, California 94143
United States
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.