Multisystem Inflammatory Syndrome In Children at Sohag University Hospital

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05382234
Collaborator
(none)
50
1
12
4.2

Study Details

Study Description

Brief Summary

Since its initial description in December 2019 in Wuhan , China, Corona virus disease 2019 (COVID-19), caused by infection with severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), has rapidly evolved into a worldwide pandemic affecting millions of lives .

Unlike adults, the vast majority of children with COVID-19 have mild symptoms. However, there are children who have significant respiratory disease, and some children may develop a hyper inflammatory response similar to what has been observed in adults with COVID-19. Furthermore, in late April 2020, reports emerged of children with a different clinical syndrome resembling Kawasaki disease (KD) and toxic shock syndrome; these patients frequently had evidence of prior exposure to SARS-CoV-2.

The pathophysiology of MIS-C:

Is unclear ,but it appears to be a consequence of a exacerbated immune system response or maladaptive response of the host .After the virus enters the human cells, the first line of defense against infection should be a quick and well-coordinated immune response ;however, when this mechanism is unregulated and excessive ,hyper inflammation can occur.

Cytokines that play an important role in inducing immunity and immunopathology during infections in excess can cause the clinical syndrome known as cytokine storm. The inflammatory response caused by SARS-CoV-2appears to be the major cause of mortality in infected patients .

The infection of dendritic cells or macrophages by SARS-CoV-2 induces the production of low levels of antiviral cytokines and increases the production of inflammatory cytokines (tumor necrosis factor[TNF], interleukin[IL]-1, IL-6,and interferon ).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: CBC, ESR ,CRP,Liver Function ,renal function ,ABG,Na,K,D-dimmer ,cardiac enzyme,ferritin ,blood and urine culture in negative cases

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Multisystem Inflammatory Syndrome In Children at Sohag University Hospital
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Confirmed or suspected cases of Multisystem inflammatory syndrome in children [1 year]

    Confirmed or suspected cases Multisystem inflammatory syndrome in children based On WHO Criteria of MIS-C Age 0-19 years. Fever for ≥3 days. Clinical signs of multi system involvement (at least 2 of the following): Rash, bilateral non purulent conjunctivitis, or mucocutaneous inflammation signs Hypotension or shock Evidence of coagulopathy (prolonged PT or PTT) Acute gastrointestinal symptoms (diarrhea , vomiting, or abdominal pain) Elevated markers of inflammation (eg ESR, CRP) No other obvious microbial cause of inflammation. Evidence of SARS-CoV-2 infection (Any of the following: Positive SARS-CoV-2 RT-PCR ,positive serology, COVID 19 exposure within the 4 weeks prior to the onset of symptoms). according to CDC criteria exposure to a patients with suspected or confirmed COVID-19 within the 4 weeks prior to the onset of symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 12 Years
Sexes Eligible for Study:
All
Inclusion Criteria:

Any suspected case of MIS-C from birth to 12 year included both sexes fulfill criteria of MIS-C (WHO) .

  1. Fever for ≥3 days.

  2. Clinical signs of multi system involvement (at least 2 of the following):

  3. Rash, bilateral non purulent conjunctivitis, or mucocutaneou inflammation signs (oral, hands, or feet)

  4. Hypotension or shock

  5. Cardiac dysfunction, pericarditis, valvulitis , or coronary abnormalities (including echocardiographic findings or elevated troponin)

  6. Evidence of coagulopathy (prolonged PT or PTT)

  7. Acute gastrointestinal symptoms (diarrhea , vomiting, or abdominal pain)

  8. Elevated markers of inflammation (eg ESR, CRP) 5. No other obvious microbial cause of inflammation. 6. Evidence of SARS-CoV-2 infection (Any of the following: Positive SARS-CoV-2 RT-PCR ,positive serology, COVID 19 exposure within the 4 weeks prior to the onset of symptoms).

according to CDC criteria exposure to a patients with suspected or confirmed COVID-19 within the 4 weeks prior to the onset of symptoms.

Exclusion Criteria:
  • Other obvious microbial cause of inflammation, including bacterial sepsis and staphylococcal/streptococcal toxic shock syndromes.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag university hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Youstena Rashed Attia, Resident docotor pediatric department Facuity Of Medicine Sohag University, Sohag University
ClinicalTrials.gov Identifier:
NCT05382234
Other Study ID Numbers:
  • Soh-Med-22-05-12
First Posted:
May 19, 2022
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2022