Early Career
Status: Funded - Open
Márcia Chiluvane, MD
Summary
BACKGROUND: Tuberculosis (TB) diagnosis in children is a global challenge due to the difficulty in obtaining sputum samples, limited sensitivity of current diagnostic tests, and non-specific clinical presentation. Evaluating cough characteristics and patterns as a screening and treatment-monitoring tool could provide a non-invasive and scalable approach to support earlier identification and treatment of pediatric TB. GAP: Cough monitoring has the potential to support TB screening in children and monitor the response to TB treatment. However, little research on the feasibility and accuracy of this approach in children has been published to date. HYPOTHESIS: Cough monitoring can distinguish cough patterns in children with TB from those with other diseases and detect longitudinal changes in cough frequency associated with treatment response. METHODS: This prospective observational cohort study aims to recruit 193 children aged <15 years with presumptive TB. Solicited coughs will be smartphone-recorded at study visits, while spontaneous cough will be smartwatch-monitored periodically for 1-2 weeks throughout the treatment course, as applicable. Prespecified spontaneous cough metrics will be assessed and evaluated for accuracy against a composite and microbiological reference standards. Longitudinal cough changes among children receiving TB treatment will be compared with a predefined composite treatment-response measure. The usability and acceptability of cough monitoring tools will be assessed among children, caregivers, and healthcare workers. RESULTS: Pending. IMPACT: This study will generate evidence on the performance and feasibility of cough monitoring for pediatric TB screening and treatment-response monitoring in settings with limited health systems capacity, potentially transforming approaches of childhood TB care.