Low-dose intravenous immunoglobulin for children with newly diagnosed immune thrombocytopenia: protocol of a systematic review and meta-analysis

Abstract

IntroductionIntravenous immunoglobulin (IVIg) is a first-line treatment for children with newly diagnosed immune thrombocytopenia (ITP). However, the cost of IVIg is high. Higher doses of IVIg are associated with a more insupportable financial burden to paediatric patients’ families and may produce more adverse reactions. Whether low-dose IVIg can quickly stop bleeding and induce a durable response in treating children with newly diagnosed ITP is not yet established.Methods and analysisWe will extensively search five English databases (PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature) and three Chinese databases (CNKI, Wanfang and VIP). International Clinical Trials Registry Platform and ClinicalTrials.gov will also be searched as supplementary. Randomised controlled trials and prospective observational studies compared the efficacy of low-dose IVIg and high-dose or moderate-dose IVIg will be included. The primary outcome is the proportion of patients achieving durable response. Estimates of effect will be pooled with either a random-effect model or a fixed-effect model according to the heterogeneity of studies. If significant heterogeneity exists, we will conduct subgroup analysis and sensitivity analysis to explore the source of heterogeneity and evaluate the robustness of the results. Publication bias will also be assessed, if possible. The risk of bias will be assessed using the Risk of Bias 2 and Risk Of Bias In Non-randomised Studies of Interventions tools. The certainty of evidence will be evaluated using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system.Ethics and disseminationNo ethical approval is required since this systematic review is based on previously published studies. The findings of this study will be presented at international conferences or published in a peer-reviewed journal.PROSPERO registration numberCRD42022384604.