Chronic wet cough in children Respiratory
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 6 months to 10 years 2. Parent reported cough for more than 4 weeks 3. Doctor observed moist / wet cough
Exclusion criteria
Exclusion criteria: 1. Gross developmental delay 2. Cystic fibrosis 3. Ex-premature birth (<36 wks) 4. Interstitial lung disease 5. Cardiac abnormalities 6. Non cystic fibrosis bronchiectasis 7. Immunodeficiency 8. Haemoptysis 9. Penicillin allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cough score will be recorded by the parent for two days prior to treatment commencing, daily during treatment and for two days after treatment completion. This validated cough scoring system correlates with objective cough counts as measured by a cough meter. It involves scoring the cough on a scale of 0-5. Cough resolution is defined as >75% reduction in the mean of the two recordings pre-treatment and the mean of the two recordings post-treatment or cessation of coughing for =3 days recorded daily during treatment. Cough score will also be recorded monthly in those who enter the 12 month follow-up as an outcome measure to assess the incidence of chronic cough relapse. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cough Specific QoL Questionnaire: The shortened parent cough-specific QoL questionnaire (PC-QOL-8) will be used. It consists of 8 questions which are scored 1-7 and has been fully validated. It covers physical, psychological and social QoL domains. It will be measured at the pre and post treatment visits to help assess the initial response to treatment and monthly in those who enter the 12 month follow-up to assess the incidence of chronic cough relapse. 2. Lung Clearance Index (LCI): LCI is a novel form of lung function. It will be measured using an InnocorTM Gas Analyser at the pre and post treatment visits to help assess the initial response to treatment. 3. Bacterial Sequencing: All isolated organisms will be identified using standard techniques and then stored on Microbank® cryogenic beads (Pro-lab Diagnostics, UK) at -70 degrees Celsius in the RSUH Microbiology Laboratory. When a child grows the same organism from an induced sputum or cough swab during an episode of chronic cough relapse that was also identified on the bronchoscopy both samples will undergo bacterial sequencing to investigate if they are genetically identical. This will identify if relapses are caused by the same organism as the initial episode. 4. Blood Markers of Bacterial Inflammation and Asthma / Atopy: At the pre-treatment visit blood samples will be taken for full blood count, total IgE, CC16, IL-5 and procalcitonin. The first four of these can be used as markers of asthma / atopy. We hypothesise that children who do not respond to antibiotics will have evidence of asthma / atopy suggesting an alternative diagnosis. Procalcitonin is a sensitive marker of bacterial induced inflammation. It can be used to predict if children with community acquired pneumonia will or will not respond to antibiotic treatment. We hypothesise that children who do not respond to antibiotics will have low levels of procalcitonin suggesting there is no bacterial | — |
Countries
United Kingdom