Asthma in Children Clinical Trial
— AMBTOfficial title:
Effects of Airway Microbiota and Blood Eosinophils Based Therapy or Treatment Using Current Clinical Guidelines in Recurrent Preschool Wheeze
Airway microbiota pattern may related the preschool asthma exacerbation. This is a single-center, randomized-controlled trial, the study will compare the management of preschool wheeze determined by airway microbiota phenotype and blood eosinophils level to the management using current clinical guidelines.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 5 Years |
Eligibility | Inclusion Criteria: - physician diagnosed recurrent wheeze(at least 3 episodes of wheezing or at least one course of oral steroids in the last 6 months) Exclusion Criteria: - Any congenital heart disease diagnosed by a physician - Any chronic respiratory condition other than preschool wheeze (bronchopulmonary dysplasia, bronchiolitis obliteran, congenital airway and lung malformations, bronchomalacia, chronic aspiration) diagnosed by a physician - Received antibiotic last 6 weeks |
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital of Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of unscheduled healthcare visits for wheezing | the number of visits for wheezing is recorded by the physician | from baseline to one year follow-up | |
Secondary | Frequency of severe wheezing requiring oral or intravenous steroids | the number of courses of an oral prednisolone or intravenous methylprednisolone started for acute wheezing after consultation with a physician, and is recorded by the physician or confirmed by the medical records | from baseline to one year follow-up | |
Secondary | Frequency of emergency department visit | the number of emergency visit is recorded by the physician and confirmed by the medical records | from baseline to one year follow-up | |
Secondary | Frequency of hospital admissions | the number of emergency visit is confirmed by the medical records | from baseline to one year follow-up | |
Secondary | The changes of TRACK score | assessed by questionnaire | from baseline to one year follow-up | |
Secondary | The changes of PACQLQ score | assessed by questionnaire | from baseline to one year follow-up |
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