The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years

The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to <14 Years

This study examines the cold processes of children aged 6 to less than 14. Children will be seen by the study staff 6 days in a row during the course of their naturally-acquired colds. Nasal secretions will be examined for chemicals that the body creates during a cold. Skin cells will be collected by brushing the inside of the child's cheek with a small brush. The cells will be examined for genes that may hold control the creation of these chemicals.

Study Overview

• Status: Completed
• Conditions: Common Cold; Upper Respiratory Infection

Detailed Description

Leukotrienes are chemicals that are naturally made by your body. Leukotrienes are increased in the bodies of adults and children with asthma and allergies and cause some of the symptoms of these diseases. Leukotrienes are increased in the bodies of adults who have common colds and are believed to cause some of the symptoms of the common cold. It is not known if increases in leukotrienes are related to the symptoms of the common cold in children. There are also genes that may control levels of leukotrienes and other chemicals in your body during the common cold. If you enroll your child in this study, he/she will be tested for allergies and for genes that may control the levels of leukotrienes and other chemicals.

STUDY DESIGN:

There will be 40 subjects enrolled into the study between the ages of 6 to < 14 years of age. However, approximately 80 participants may have to sign the consent form and undergo screening activities in order enroll these 40 subjects. The study will last approximately 1 month and will require you and your child to return to our clinic approximately 7 times over the study duration. You and your child will be required to return to our clinic six days in a row for testing.

Testing will include skin testing for allergies, nasal secretion collection, and skin cell collection.

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and Female subjects ages 6 to under 14 years with common cold symptoms of less than 24 hours in duration.

Description

Inclusion Criteria:

• Children 6 to < 14 years of age.
• Common cold symptoms for less than 24 hours.
• At least 2 of the following 8 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, and sneezing.

Exclusion Criteria:

• Investigational medication in past 30 days.
• History of persistent asthma or other chronic diseases.
• Patients with nasal ulcers within the past 1 month, nasal surgery within the past 6 months, nasal trauma within the past 2 months or presence of nasal polyps or nasal deformities causing significant nasal obstruction.
• Patients with evidence of significant nasal septal deviation.
• Patients with a positive rapid antigen test for streptococcal infection.
• Common cold symptoms for more than 24 hours.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Confirmed respiratory virus
Unconfirmed respiratory infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Leukotriene Levels	nasal secretions were collected once a day for the first six days of the respiratory infection and on day 30 then measured for leukotriene levels	once a day for 6 days and on day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal Secretion Weights	Nasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight	each day for 5 days
Severity of Symptom Scores - COUGH	Cough symptoms were rated by the participant each day for 6 days and on day 30. Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.	once a day for six days and on day 30
Severity of Symptom Score - NASAL CONGESTION	nasal congestion symptoms were rated by the participant once a day for six days and on day 30. Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.	once a day for six days and on day 30
Severity of Symptom Score - SNEEZING	Sneezing symptoms were rated by participants once a day for six days and on Day 30, symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.	once a day for six days and on Day 30

Collaborators and Investigators

• Sponsor: West Penn Allegheny Health System
• Collaborators: Merck Sharp & Dohme LLC; Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: November 28, 2006
• First Submitted That Met QC Criteria: November 28, 2006
• First Posted (Estimate): November 30, 2006

Study Record Updates

• Last Update Posted (Estimate): August 19, 2016
• Last Update Submitted That Met QC Criteria: July 20, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Common Cold; Upper Respiratory Infection
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Disease Attributes; Picornaviridae Infections; Infections; Communicable Diseases; Respiratory Tract Infections; Common Cold
• Other Study ID Numbers: RC#4065