UMOYA: a prospective longitudinal cohort study to evaluate novel diagnostic tools and to assess long-term impact on lung health in South African children with presumptive pulmonary TB—a study protocol
Year: 2023
Type: article
Study design: Study Protocol
Abstract: BACKGROUND: Despite a high paediatric tuberculosis (TB) burden globally, sensitive and specific diagnostic tools are lacking. In addition, no data exist on the impact of pulmonary TB on long-term child lung health in low- and middle-income countries. The prospective observational UMOYA study aims (1) to build a state-of-the-art clinical, radiological, and biological repository of well-characterised children with presumptive pulmonary TB as a platform for future studies to explore new emerging diagnostic tools and biomarkers for early diagnosis and treatment response; and (2) to investigate the short and long-term impact of pulmonary TB on lung health and quality of life in children. METHODS: We will recruit up to 600 children (0-13 years) with presumptive pulmonary TB and 100 healthy controls. Recruitment started in November 2017 and is expected to continue until May 2023. Sputum and non-sputum-based samples are collected at enrolment and during follow-up in TB cases and symptomatic controls. TB treatment is started by routine care services. Intensive follow-up for 6 months will allow for TB cases to retrospectively be classified according to international consensus clinical case definitions for TB. Long-term follow-up, including imaging, comprehensive assessment of lung function and quality of life questionnaires, are done yearly up to 4 years after recruitment. DISCUSSION: The UMOYA study will provide a unique platform to evaluate new emerging diagnostic tools and biomarkers for early diagnosis and treatment response and to investigate long-term outcomes of pulmonary TB and other respiratory events on lung health in children.
Source: BMC Pulmonary Medicine
Authors: Isabelle Dewandel, Margaret van Niekerk, Elisabetta Ghimenton-Walters, Megan Palmer, Michaile G. Anthony, Carla McKenzie, Rolanda Croucamp, Galit Alter, Anne-Marie Demers, Gert van Zyl, Mathilda Claassen, Pierre Goussard, Ruan Swanepoel, Graeme Hoddinott, Corne Bosch, Rory Dunbar, Brian Allwood, Eric D. McCollum, H. Simon Schaaf, Anneke C. Hesseling, Marieke M. van der Zalm
Institutions: Stellenbosch University, National Health Service, Ragon Institute of MGH, MIT and Harvard, Moderna Therapeutics (United States), Massachusetts Institute of Technology, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, National Health Laboratory Service, Tygerberg Hospital, Johns Hopkins University, Johns Hopkins Medicine
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,790
Awards: The long-term consequences of pulmonary tuberculosis and respiratory viruses on lung health in young South African children, G1131907842, The long-term consequences of pulmonary tuberculosis and respiratory viruses on lung health in young South African children, Multiplexed Antigen-Specific Antibody Fc Profiling on a Chip for Point-of-Care Diagnosis of TB in HIV-infected Children
OpenAlex ID: W4353064101