Serial inflammatory responses in children receiving different treatment regimen for Multisystem Inflammatory Syndrome (MIS-C) - Longitudinal observational study from Southern India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The expected results of this study are likely to help our understanding of MIS-C & the different treatment options, which might help us to formulate a protocol or guidance for the management of MIS-C.
研究概览
简要总结
Multisystem Inflammatory Syndrome (MIS-C) is acomplication of SARS-CoV-2 infection in children, which occurs 3-4 weeks afterthe acute infection due to a cytokine storm. Intravenous immunoglobulins (IVIG)and Steroids (Methyl prednisolone) are the main stay of treatment. However, we are yet to fully understand the immumopathologicalrole of these treatments in MIS-C. Most of the clinicians and institutionsaround the world use both IVIG and Steroids, but few use either one of them.Early reports and experience of paediatricians suggest that different regimenseem to work equally. However, there is no evidence in identifying the righttreatment pathway. Evidence is therefore, urgently needed to support treatmentdecisions for children with MIS-C. Through this study, we aim to evaluate the efficacy of different treatment regimen followed in variousPaediatric intensive care units across Chennai, India in the management ofMIS-C to reach a consensus.
Stored plasma samples from children aged 0 to ≤18 years, admitted to PICUs of various hospitals across Chennai, with MIS-Cwill be included in the study. We will be analysing the following on stored samples:
· IL-6,IFNγ, TNFα, IL-2, IL-10, MIP-1a, GM-CSF, MCP-1, MI-1a
· Neutrophilelastase, plasmin and alpha-1-antitrypsin
· ProBnPand Troponin
Analysis will be performed on the 3main groups formed based on the treatment received:
1)IVIG plus MPS; 2) IVIG alone; 3) MPS alone
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children and Adolescents who meet the criteria for CDC case definition of Multisystem inflammatory Syndrome.
排除标准
- •Caretakers and children who have not consented
- •Children admitted to PICU for conditions other than MIS-C
- •Children on long term steroid and immunosuppressant therapy
- •Children with Adrenocortical insufficiency
- •Children with congenital or acquired immunodeficiency
- •Children who have received steroids before enrolment into study.
结局指标
主要结局
The expected results of this study are likely to help our understanding of MIS-C & the different treatment options, which might help us to formulate a protocol or guidance for the management of MIS-C.
时间窗: •Median cytokine levels (various cytokines) at day 0, day 2-3, & at day 5-7 | •Reduction in proportion of cytokine levels in each group
次要结局
- •Correlation of cardiac markers with disease manifestation(•Correlation of Gene polymorphisms with disease manifestation)