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

Signs and Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01814293
• Other study ID #: 12-10271
• Status: Withdrawn
• Phase: N/A
• First received: March 13, 2013
• Last updated: May 13, 2015
• Start date: May 2013
• Est. completion date: September 2013

Study information

• Verified date: May 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Upper Respiratory Infection
• Communicable Diseases
• Infection
• Respiratory Tract Infections
• Signs and Symptoms

Intervention

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.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Vapore, LLC

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	URI (upper respiratory infection) symptoms one day after ED visit	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.	1 day	No
Primary	URI (upper respiratory infection) symptoms 2 days after ED visit	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.	1 day	No
Secondary	URI (upper respiratory infection) revisits	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.	2 days	No

External Links

•   American Academy of Pediatrics Advocacy Statement on Over the Counter Cough and Cold Medications for Pediatric Uses.
•   Food and Drug Administration (FDA) released recommendations regarding use of over- the-counter cough and cold products.