The predictive role of small airway dysfunction and airway inflammation biomarkers for asthma in preschool and school-age children: a study protocol for a prospective cohort study

BACKGROUND: Preschool children are at a high risk of developing asthma. Asthma in preschool children could remit in most cases, but could persist into school age, adolescence, or even adulthood in some cases. However, it is difficult to predict which children with preschool asthma will develop into school-age asthma. We present a cohort study protocol to explore the predictive role of small airway dysfunction and airway inflammation biomarkers of asthma in preschool and school-age children. METHODS: A prospective cohort study will be conducted with at least 205 children with preschool asthma. All patients will be recruited when they consult a pediatric pulmonologist at the Children’s Hospital of Chongqing Medical University and will be followed up to 6 years of age. Initially, patients’ demographic information, medical history, physical findings, and questionnaire information will be collected, and baseline small airway function and inflammation biomarkers will be detected. During the follow-up period, medical history, physical findings, and the questionnaire results will be collected every 3 months, and small airway function will be tested by impulse oscillometry (IOS) every 6 months. At the final visit, a definite diagnosis of school-age asthma will be made by a pediatric pulmonologist based on the criteria of the Global Initiative for Asthma 2020. DISCUSSION: The study will be the first to be conducted in preschool children assessing whether small airway dysfunction combined with airway eosinophilic biomarkers and club cell secretory protein is associated with school-age asthma. This study may provide new promising predictors of persistent asthma from preschool to school age. TRIAL REGISTRATION: The study has been registered at the Chinese Clinical Trial Registry (ChiCTR2000039583). Registered on November 1, 2020. Protocol version: version 1.0, August 16, 2021.