Li Qinyuan, Zhou Qi, Li Yuanyuan, Liu Enmei, Fu Zhou, Luo Jian, Liu Sha, Liu Fangjun, Chen Yaolong, Luo Zhengxiu
Department of Respiratory Medicine, Children's Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Pediatrics, Chongqing, China.
Evidence-based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China.
Transl Pediatr. 2021 Oct;10(10):2630-2638. doi: 10.21037/tp-21-239.
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.
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.
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.
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.
学龄前儿童患哮喘的风险很高。大多数情况下，学龄前儿童哮喘可以缓解，但在某些情况下可能会持续到学龄期、青春期甚至成年期。然而，很难预测哪些患有学龄前哮喘的儿童会发展为学龄期哮喘。我们提出一项队列研究方案，以探讨哮喘的小气道功能障碍和气道炎症生物标志物在学龄前和学龄期儿童中的预测作用。
将对至少205名患有学龄前哮喘的儿童进行前瞻性队列研究。所有患者在重庆医科大学附属儿童医院咨询儿科肺科医生时被招募，并随访至6岁。最初，将收集患者的人口统计学信息、病史、体格检查结果和问卷信息，并检测基线小气道功能和炎症生物标志物。在随访期间，每3个月收集一次病史、体格检查结果和问卷结果，每6个月通过脉冲振荡法（IOS）检测一次小气道功能。在最后一次就诊时，儿科肺科医生将根据《2020年全球哮喘防治创议》的标准对学龄期哮喘做出明确诊断。
该研究将是首次在学龄前儿童中进行，评估小气道功能障碍与气道嗜酸性粒细胞生物标志物和克拉拉细胞分泌蛋白相结合是否与学龄期哮喘相关。本研究可能为从学龄前到学龄期持续性哮喘提供新的有前景的预测指标。
该研究已在中国临床试验注册中心注册（ChiCTR2000039583）。于2020年11月1日注册。方案版本：2021年8月16日第1.0版。
