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

NCT01814293 | Withdrawn

• 1 other identifier: 12-10271
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Upper Respiratory Infection; Signs and Symptoms

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• URI (upper respiratory infection) revisits

  2 days

Study Arms (2)

Handheld humidifier

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

Subjects will manage cold symptoms with any desired supportive over the counter treatment, and complete surveys related to symptom scores and modalities used.

Interventions

Handheld humidifier DEVICE

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.

Also known as: MyPurMist (specific handheld humidifier used in this trial)

Handheld humidifier

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Vapore, LLC: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (13)

• Gunn VL, Taha SH, Liebelt EL, Serwint JR. Toxicity of over-the-counter cough and cold medications. Pediatrics. 2001 Sep;108(3):E52. doi: 10.1542/peds.108.3.e52.

  PMID: 11533370 BACKGROUND

• Kuehn BM. FDA: cold medications risky for young children. JAMA. 2007 Sep 12;298(10):1151. doi: 10.1001/jama.298.10.1151. No abstract available.

  PMID: 17848645 BACKGROUND

• 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.

  PMID: 19047249 BACKGROUND

• 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.

  PMID: 19482755 BACKGROUND

• 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. doi: 10.1542/peds.114.1.e85.

  PMID: 15231978 BACKGROUND

• 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.

  PMID: 17218934 BACKGROUND

• 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.

  PMID: 19101060 BACKGROUND

• 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.

  PMID: 18676517 BACKGROUND

• 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.

  PMID: 21199854 BACKGROUND

• Muller-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. doi: 10.1055/s-2006-932548. German.

  PMID: 16511738 BACKGROUND

• 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. doi: 10.1007/BF02714035.

  PMID: 3130530 BACKGROUND

• 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. doi: 10.1016/j.burns.2007.07.016. Epub 2007 Oct 22.

  PMID: 17954012 BACKGROUND

• 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. doi: 10.1002/14651858.CD005075.pub2.

  PMID: 16856075 BACKGROUND

MeSH Terms

Conditions

Signs and Symptoms; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Infections; Respiratory Tract Diseases

Study Officials

• Jacqueline A Nemer, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 19, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 15, 2015

Record last verified: 2015-05

Locations

US (1)