The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 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.
Upper Respiratory Infection
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to <14 Years|
- Local Leukotriene Levels [ Time Frame: once a day for 6 days and on day 30 ] [ Designated as safety issue: No ]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
- Nasal Secretion Weights [ Time Frame: each day for 5 days ] [ Designated as safety issue: No ]Nasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight
- Severity of Symptom Scores - COUGH [ Time Frame: once a day for six days and on day 30 ] [ Designated as safety issue: No ]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.
- Severity of Symptom Score - NASAL CONGESTION [ Time Frame: once a day for six days and on day 30 ] [ Designated as safety issue: No ]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.
- Severity of Symptom Score - SNEEZING [ Time Frame: once a day for six days and on Day 30 ] [ Designated as safety issue: No ]Sneezing symptoms were rated by participants once a day for six days and on Day 30
Biospecimen Retention: Samples With DNA
Buccal brushing for genotyping
|Study Start Date:||October 2006|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
|Confirmed respiratory virus|
|Unconfirmed respiratory infection|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405509
|United States, Pennsylvania|
|Allegheny General Hospital|
|Pittsburgh, Pennsylvania, United States, 15212|
|Principal Investigator:||Deborah Gentile, MD||West Penn Allegheny Health System|