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