The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to <14 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Local Leukotriene Levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Local Leukotriene Levels
时间窗: once a day for 6 days and on day 30
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
次要结局
- Nasal Secretion Weights(each day for 5 days)
- Severity of Symptom Scores - COUGH(once a day for six days and on day 30)
- Severity of Symptom Score - SNEEZING(once a day for six days and on Day 30)
- Severity of Symptom Score - NASAL CONGESTION(once a day for six days and on day 30)
研究者
Deborah Gentile
Director of Research, Allergy and Asthma Institute
West Penn Allegheny Health System