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

• ClinicalTrials.gov Identifier: NCT01814293
• Recruitment Status: Withdrawn
• First Posted: March 19, 2013
• Last Update Posted: May 15, 2015
• Sponsor: University of California, San Francisco
• Collaborator: Vapore, LLC
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Upper Respiratory Infection; Signs and Symptoms	Device: Handheld humidifier	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Comparison of Supportive Therapies for Symptom Relief From Pediatric Upper Respiratory Infections (URIs)
• Study Start Date: May 2013
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: September 2013

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: up to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

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

Publications:

Gunn VL, Taha SH, Liebelt EL, Serwint JR. Toxicity of over-the-counter cough and cold medications. Pediatrics. 2001 Sep;108(3):E52.

Kuehn BM. FDA: cold medications risky for young children. JAMA. 2007 Sep 12;298(10):1151.

Vernacchio L, Kelly JP, Kaufman DW, Mitchell AA. Pseudoephedrine use among US children, 1999-2006: results from the Slone survey. Pediatrics. 2008 Dec;122(6):1299-304. doi: 10.1542/peds.2008-0284.

Lokker N, Sanders L, Perrin EM, Kumar D, Finkle J, Franco V, Choi L, Johnston PE, Rothman RL. Parental misinterpretations of over-the-counter pediatric cough and cold medication labels. Pediatrics. 2009 Jun;123(6):1464-71. doi: 10.1542/peds.2008-0854.

Paul IM, Yoder KE, Crowell KR, Shaffer ML, McMillan HS, Carlson LC, Dilworth DA, Berlin CM Jr. Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents. Pediatrics. 2004 Jul;114(1):e85-90.

Centers for Disease Control and Prevention (CDC). Infant deaths associated with cough and cold medications--two states, 2005. MMWR Morb Mortal Wkly Rep. 2007 Jan 12;56(1):1-4.

Dart RC, Paul IM, Bond GR, Winston DC, Manoguerra AS, Palmer RB, Kauffman RE, Banner W, Green JL, Rumack BH. Pediatric fatalities associated with over the counter (nonprescription) cough and cold medications. Ann Emerg Med. 2009 Apr;53(4):411-7. doi: 10.1016/j.annemergmed.2008.09.015. Epub 2008 Dec 19.

Rimsza ME, Newberry S. Unexpected infant deaths associated with use of cough and cold medications. Pediatrics. 2008 Aug;122(2):e318-22. doi: 10.1542/peds.2007-3813.

Daftary AS, Deterding RR. Inhalational lung injury associated with humidifier "white dust". Pediatrics. 2011 Feb;127(2):e509-12. doi: 10.1542/peds.2010-1312. Epub 2011 Jan 3.

Müller-Wening D, Koschel D, Stark W, Sennekamp HJ. [Humidifier-associated disease in the general population]. Dtsch Med Wochenschr. 2006 Mar 10;131(10):491-6. German.

Baur X, Behr J, Dewair M, Ehret W, Fruhmann G, Vogelmeier C, Weiss W, Zinkernagel V. Humidifier lung and humidifier fever. Lung. 1988;166(2):113-24.

Wallis BA, Turner J, Pearn J, Kimble RM. Scalds as a result of vapour inhalation therapy in children. Burns. 2008 Jun;34(4):560-4. Epub 2007 Oct 22.

Donnelly D, Everard MM, Chang AB. Indoor air modification interventions for prolonged non-specific cough in children. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD005075. Review.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01814293 History of Changes
• Other Study ID Numbers: 12-10271
• First Posted: March 19, 2013
• Last Update Posted: May 15, 2015
• Last Verified: May 2015

Keywords provided by University of California, San Francisco:

Pediatric; Upper Respiratory infection; Over the Counter Drugs; Drugs, Non-Prescription; Vaporizer

Additional relevant MeSH terms:

Infection; Communicable Diseases; Respiratory Tract Infections; Signs and Symptoms; Respiratory Tract Diseases