Natural history, clinical outcomes and predictors of disease course in paediatric IgA vasculitis: protocol for a multicentre prospective cohort study in Guangxi Zhuang Autonomous Region, China

Abstract

INTRODUCTION IGA VASCULITIS IGAV, FORMERLY HENOCH-SCHÖNLEIN PURPURA IS A SYSTEMIC SMALL-VESSEL VASCULITIS THE AETIOLOGY OF IGAV IS MULTIFACTORIAL, INVOLVING ENVIRONMENTAL TRIGGERS IN GENETICALLY SUSCEPTIBLE INDIVIDUALS EVOLVING SOCIOECONOMIC AND ENVIRONMENTAL FACTORS MAY BE ALTERING THE CONTEMPORARY AETIOLOGICAL AND PRECIPITANT SPECTRUM OF IGAV PROSPECTIVE OBSERVATIONAL STUDIES ARE THEREFORE CRUCIAL FOR ELUCIDATING DISEASE MANAGEMENT, PROGNOSTIC FACTORS AND LONG-TERM OUTCOMES ALTHOUGH NUMEROUS STUDIES EXIST ON PAEDIATRIC IGAV, PROSPECTIVE COHORT DATA REMAIN LIMITED THIS MULTICENTRE PROSPECTIVE OBSERVATIONAL STUDY AIMS TO CHARACTERISE THE NATURAL HISTORY, AETIOLOGICAL/PRECIPITANT SPECTRUM, INCIDENCE AND OUTCOMES OF GASTROINTESTINAL AND RENAL INVOLVEMENT, FACTORS INFLUENCING THERAPEUTIC EFFICACY AND THE PREDICTIVE VALUE OF BIOMARKERS FOR DISEASE ACTIVITY: METHODS AND ANALYSIS: We will recruit 478 paediatric patients with newly diagnosed IgAV across multiple centres. Participants will undergo prospective longitudinal assessment at disease onset and at 1, 3, 6 and 12 months postdiagnosis. Standardised evaluations will include clinical manifestations, physical examinations, laboratory parameters and patient-reported outcomes. The data will be analysed statistically with SPSS software (V.27.0), adopting a significance threshold of p<0.05 and using 95% CIs for statistical inference. ETHICS AND DISSEMINATION: This study has been approved by the Medical Ethics Committee of the First Affiliated Hospital of Guangxi Medical University (2024-K0480), the Ethics Committee of the First People's Hospital of Yulin (YLSY-IRB-SR-2025060), the Medical Research Ethics Committee of the Liuzhou Workers' Hospital (KY2024356) and the Ethics Committee of the Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region (No. (2025-1)003) and written informed consent was obtained from all the parents or guardians of the patients involved. It will be disseminated by publication of peer-reviewed manuscripts and presentation in abstract form at national and international scientific meetings. TRIAL REGISTRATION NUMBER: ChiCTR2500099716.

Keywords: Child; Clinical Protocols; Immunity; PAEDIATRICS.