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

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).

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.