跳至主要内容
临床试验/CTRI/2020/11/029061
CTRI/2020/11/029061招募中不适用

Clinical profile and outcome of Multisystemic inflammatory syndrome in children (MIS-C) in COVID pandemic – An observational study from a paediatric tertiary care centre

ICH HC Madras Medical College Chennai1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年11月29日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Time forn ormalisation of clinical symptoms of fever and rash

研究概览

简要总结

Multisystem inflammatory syndrome in children is a new entity beingdiagnosed  in the recent few months inchildren  during  and following covid infection in thispandemic. The spectrum of MIS-C can present with   mildsymptoms or typical Kawasaki like illness or like  atypical Kawasaki like illness or toxic  shock syndrome like or  with macrophage activation syndrome. This  is named as  MIS –C(by WHO & CDC) or  PIMSTS (pediatric  multisystem inflammatorysyndrome  temporally associated withSARS- Covid 19) by different  groups . Childrenrarely become sick to be hospitalized  in comparison to adults with Covid infection.  Majority of the studies  have shown the involvement as postinflammatory  rather than with acuteinfection in children . Once they develop MIS C  they may needhospitalization and if sick  theyneed  intensive care and therapy withIVIG.

  Current  information  on this new clinical condition is based onthe western literature  who had theirpandemic  little earlier than  India. Majority of the  literature suggests that the presentation isusually  following the covid-19  peak among adults.This usually occurs  3-4 weeks contact or infection  in children. Based on the recently published literature elsewhere majority of thesechildren were found to be negative for the covid 19 viral PCR but have  IgGantibodies  to COVID 19. The World Health Organization (WHO) has created a workinggroup of experts from all over the world to begin investigating cases toestablish evidence on whether Covid-19 can lead to multiorgan failure also inthis age group.CDC and WHO defines this condition as  multisystem inflammatory syndrome  in children,  MIS-C and  as a serious complication of the disease. Thishas also been defined as pediatric multisystem inflammatory syndrome inchildren temporally associated with SARS Covid 19  called PIMS-TS.  Not much  literature is available as on date fromIndia  regarding this newly coineddisease. Based on the available literature from Europe and North America  clinical presentation can be mild, moderateor severe  disease resulting in mortalityif not recognized.  Mild diseasewithout  shock or  severe cardiac involvement or any other  significant organ involvement  may not  need any specific treatment   whilethe moderate and severe ones may need ICU  treatment with IVIG/and Methylprednisolone and/or biologicals like  Tocilizumab therapy. But for occasional case  reports  of the condition  from India it is yet  to be familiar  to the pediatricians. Not  many pediatricians  are aware of such clinical  conditions in the absence of literature fromIndia and this disease is likely to increase  following  the adultpeak of COVID infection  in different parts of the country.

 Recently the PediatricIntensive Care unit  of ICH &HC  has encountered  increasing  number of children with features  suggestive of this multisystem inflammatory syndrome, which  varies from mild symptomatic  with no multiorgan involvement  to severe involvement in the form of Kawasakidisease  like, atypical Kawasaki disease(KD) like ,  toxic shock syndrome (TSS)likein  vasoplegic  shock and  macrophage activation syndrome (MAS) phenotypes .   The data over past  5 weeks in PICU has shown analarmingly increasing  number of approximately10 times.in number  with features ofsevere involvement of  heart, and otherorgans like  liver , kidney ,  pancreas other multi organ dysfunction syndrome. Some of these children in  intensive care  were started on   multiple inotropes, and  ventilator support too , with ejectionfraction as low as 15 %.  Though thisKD   phenotype has differences from typical Kawasaki disease.  IVIG  alone or  along with methylprednisolone has been thesuggested modality of therapy based on the severity of myocardial involvement.MAS  is life threatening and unlessrecognized  mortality is high. .Due tothe variant nature of the disease and the temporal association  to covid,  the  course and outcome  and long term follow up need to be studied.  These children need  to be followed up   for their morbidity  as there is no existing literature on thisnewly identified life threatening disease in children.

The use of  immunomodulants  like IVIG  with or withoutmethylprednisolone are  used  in the acute phase of KD in children can  be expected  to reduc incidence of coronary arteryaneurysms, duration of clinical symptoms (fever, rash), time for laboratoryparameters to normalise (CRP, ESR) and length of hospital stay .In the absenceof   much published   literature from India on this  condition, itis prudent to have  regional data and thepresentation of children their course and outcome .

Childrenwith  hyperinflamatory syndrome are  much older, more likely to have  gastrointestinal symptoms like vomiting ,diarrhea  abdominal pain. Thesechildren  are  likely to  have a spectrum  of  features  involving  multiple organs .  The lab parameters  are more likely to be thrombocytopenia   lower absolute  lymphocyte counts lymphopenia and muchhigher  CRP levels..

There is  an urgent need to studythe presentation of these children and plan for appropriate management  as a team . ICH &HC being the apex  pediatric institute in the state,  is  oneof the high load  centers and there is anurgent need to study  the diseasespectrum and its outcome in our setting as it  is evolving .

  1. Objectives / Aim

(a) To study the clinical presentation and course of  Multisystemic inflammatory syndrome in

children(MIS-C)/Pediatricmultisystem inflammatory syndrome in children temporally

associated with SARS COVID 19(PIMS-TS)

(b)To correlate the laboratoryparameters and   outcome of  children with MIS-C/ PIMS -TS

(c) Follow up of children withMIS-C/PIMS –TS  over  a period of 12 months

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children admitted to PICU with MIS-C.

排除标准

  • Non MIS-C Children.

结局指标

主要结局

Time forn ormalisation of clinical symptoms of fever and rash

时间窗: 3, 6, 9 ,12 months

Time for normalization of lab abnormalities of inflammatory markers ESR CRP

时间窗: 3, 6, 9 ,12 months

To identify the different phenotypes of MIS-C. spectrum

时间窗: 3, 6, 9 ,12 months

次要结局

  • Incidence of complications related to therapy(Length of hospital stay)

研究者

发起方
ICH HC Madras Medical College Chennai
申办方类型
Government medical college

研究点 (1)

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