BPSU study - Multisystem inflammatory syndrome, Kawasaki disease and toxic shock syndrome

Surveillance of multisystem inflammatory syndrome has now commenced. Our aim is to understand the incidence, presenting features, laboratory features, management, clinical course and the outcome of this potentially new syndrome characterised by hyperinflammation which is temporally associated with COVID-19. A better understanding of the illness will help improve the way we look after such children and may lead to new treatment and prevention strategies in the future.

Lead investigators

Dr Shamez Ladhani,
Consultant Paediatrician (infectious disease)
Immunisation and Countermeasures Division,
Public Health England,
National Infection Service,
61 Colindale Avenue,
London NW9 5EQ
Email: shamez.ladhani@phe.gov.uk

Dr Godwin Oligbu,
Consultant paediatrician,
Immunisation and Countermeasures Division,
Public Health England,
National Infection Service,
61 Colindale Avenue,
London NW9 5EQ
Email: godwin.oligbu@nhs.net

About the study

During April 2020, a number of children became very unwell with symptoms and signs of hyperinflammation and were admitted to the paediatric intensive care units. Many children had symptoms common to both Kawasaki disease, which causes inflammation of the arteries, and toxic shock syndrome, a rare life-threatening immune reaction to certain infections. Some children had predominantly gastrointestinal presentations, with abdominal pain, vomiting and diarrhoea. Around half the children with this condition in London were also positive for SARS-CoV-2. Although such cases are rare, they have been reported in different regions of the UK and in cities across Europe and the United States that have been affected by COVID-19. At present, we do not understand the relationship between SARS-CoV-2 and this new condition, or even if there is one. We will ask paediatricians to report all cases which have features of this multisystem inflammation. 

We also plan to ask paediatricians to report cases of Kawasaki disease and toxic shock syndrome to assess whether their incidence has increased compared to recent BPSU estimates for both conditions – and to determine any role of COVID-19. Collecting data on these two conditions may also help assess any differences in clinical disease, course and outcomes compared to the hyperinflammatory syndrome which is temporally associated with COVID-19, but may or may not be caused by it.  

Case definition

Any child aged <16 years with 1 OR 2 OR 3 since 1 March 2020 regardless of COVID-19 status:

  1. Evidence of hyperinflammation:

      a.   Fever >38 oC AND 
      b.   CRP >100 mg/L AND
      c.   With one or more of the following:
                 i.   Cardiac involvement (any one of the following)
                          •   myocarditis/pericarditis/valvulitis OR
                          •   coronary artery involvement (echo) OR 
                          •   cardiac failure/arrest.
                 ii.   Gastrointestinal involvement (any one of the following)
                          •   vomiting/diarrhoea OR
                          
    •   an acute abdomen OR
                          
    •   abnormal liver function(LFTs/clotting).
                 iii.   Respiratory failure (requiring any one of the following)
                          •   high flow and humidified oxygen (HFHO) OR
                          
    •   CPAP OR
                          
    •   ventilation.
                 iv.   Raised Ferritin (>500) +/- Raised D-dimers (>2x upper limit of normal).
      d.   AND no pathogen (except SARS-CoV-2) or diagnosis (e.g. confirmed appendicitis).
     
  2. Typical or atypical Kawasaki Disease.
     
  3. Typical or atypical Toxic Shock Syndrome.

Reporting instructions

Please report any child seen in the last month who meets the above case definition in the UK and the Republic of Ireland.

Duration

March 2020 - March 2021 (13 months of surveillance) or until sufficient case reports have been notified to allow data analysis.

Funding

This study is funded through a grant from Public Health England.

Approval

PHE has legal permission under Regulation 3 of The Health Service (Control of Patient Information) Regulations 2002, to conduct national surveillance of communicable diseases in England and, as such, individual patient consent is not required.

Public Health Wales, through the establishment order legislation, is required to conduct surveillance of communicable diseases in Wales and, as such, individual patient consent is not required.

PBPP application for Scotland has been applied for and we are working to get permission for Northern Ireland as a matter of urgency.

Privacy notice

Public Health England (PHE) is the sponsor and data controller for this research study. The Head of Governance at PHE can be contacted at elizabeth.coates@phe.gov.uk.

The study team at PHE will use information from medical records for a medical research study. PHE has legal permission, provided by Regulation 3 of The Health Service (Control of Patient Information) Regulations 2002, to process patient confidential information for national surveillance of communicable diseases. As such, individual patient consent is not required. We will collect information about children with a diagnosis of multisystem inflammatory syndrome from the doctors who are looking after them. Doctors will not provide identifying information like names and addresses, but they will provide personal information like sex, ethnic group and date of birth. The smallest amount of personal information will be used. We cannot withdraw or remove information from the study but personal information will be deleted or de-personalised when the study finishes. PHE will securely store this information for 20 years. 

If you want access to the information in your child’s NHS records, then you should contact your child’s NHS hospital/doctor. 

If you want to find out more about how personal information is used in the study, please contact godwin.oligbu@nhs.net.

If you wish to complain about the use of your personal information, then you should contact the Information Commissioner’s Office:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire SK9 5AF

Helpline number: 0303 123 1113
Email: casework@ico.org.uk

Support groups

Partners

Other forms of paediatric COVID-19 data collection

RCPCH has produced guidance for paediatricians and health professionals on how to accurately collect and record data on patients with suspected or confirmed cases of COVID-19 using existing surveillance and data collection sources.

Public Health England is also conducting clinical surveillance in children aged 29 days to <16 years through an online questionnaire. Paediatricians managing children with confirmed COVID-19 can contact shamez.ladhani@phe.gov.uk for more information or, alternatively, report the case directly to phe.paedCOVID@nhs.net, and will receive an email link to complete the online questionnaire.