Condition category
Not Applicable
Date applied
06/07/2020
Date assigned
14/07/2020
Last edited
15/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Ever since the first cases of SARS-CoV-2 were reported in Europe, and since the initial outbreak in Italy in February 2020, the pandemic has caused significant challenges for health care systems and the societies at large across Europe.

One of the few reassuring aspects of this pandemic might be that children don’t appear to get infected as often as adults, that severe disease in children is rare, and that children appear to play a limited role in the transmission of the virus. As a result, numbers of children attending hospital emergency departments have been reported to have fallen drastically. However, the reduced numbers appear to be out of keeping with what was to be expected as a result of the government ‘lockdown’ policies. It is thought that, as a result of the imposed restrictions on free movements by governments, children are not cross-infecting one another with other common childhood diseases with the closure of daycare facilities and schools, that they are less exposed to air pollution triggering the respiratory disease, and that they are less often involved in high velocity, traffic-related trauma.

Also, as an unwanted effect of the pandemic, frontline clinicians are noticing an increase in delayed presentations of children with serious illness. Furthermore, cases of children presenting with an emerging Paediatric Inflammatory Multisystem Syndrome - temporally associated with Sars-Cov-2 (PIMS-TS) have been reported, with some of these children testing positive and some testing negative for SARS-CoV-2. At present, no there is no evidence to confirm these findings across multiple European countries. Therefore, it is important to describe current patterns of children presenting to paediatric emergency departments across Europe and compare these with historical data. The aim of this is to provide evidence for changes to attendance to emergency departments for children; to monitor for possible new diseases; and to understand the timeliness of their presentations in relation to the disease severity, to confirm if children are attending emergency departments later than normal during the pandemic and therefore have more severe symptoms by the time they are first seen by healthcare staff.

This study will be performed by the EPISODES study steering group, in collaboration with the European Society of Emergency Medicine and the Research in European Paediatric Emergency Medicine network.

Who can participate?
The collective data of all children presenting to the emergency departments of the participating centres during the period between January 1st, 2018 and May 1st, 2020 will be included in this trial.

What does the study involve?
This study will involve analysis of routinely collected clinical data of all children presenting to emergency departments across Europe over a 2 and half year period. The data will not be identifiable and will be collected on a monthly basis for each individual participating centre during the period spanning the COVID-19 pandemic (beginning February 2020). The historical data (from January 2018 and prior to February 2020) will be collected to serve as a comparison.

What are the possible benefits and risks of participating?
As this study does not involve any change to the care of the children whose data is included and that no individual patient data or identifiable data will be collected, there are not thought to be any risks involved in this study. It is hoped that data will show the impact of the COVID-19 pandemic on the numbers of children presenting to emergency departments across Europe and may, therefore, be used to provide advice on emergency department attendance for children, and to respond rapidly to a potential second wave of the pandemic.

Where is the study run from?
Imperial College London (UK). There are currently 40 confirmed participating sites (1-4 centres per European country) providing data for the study.

When is the study starting and how long is it expected to run for?
From June to October 2020

Who is funding the study?
The study is investigator-initiated and funded.

Who is the main contact?
Dr Ruud Nijman
r.nijman@imperial.ac.uk

Trial website

https://www.eusem.org/news/564-help-research-in-paediatric-emergency-medicine-moving-forward

Contact information

Type

Scientific

Primary contact

Dr Ruud Nijman

ORCID ID

https://orcid.org/0000-0001-9671-8161

Contact details

St Marys Campus
Medical School Building
Room 235
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)7442360730
r.nijman@imperial.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 284008

Study information

Scientific title

The epidemiology, severity, and outcomes of children presenting to emergency departments across Europe during the SARS-COV-2 pandemic: the EPISODES study

Acronym

EPISODES

Study hypothesis

This study aims to describe current patterns of children presenting to paediatric emergency departments across Europe during the SARS-CoV-2 pandemic and compare these with historical data, to understand the timeliness of their presentations in relation to the disease severity, and to monitor for emerging disease entities.

Ethics approval

Approved 18/06/2020, UK HRA, Imperial College Research Governance and Integrity Team (Joint Research Compliance Office Office Room 221, Medical School Building, St Mary's Campus, Imperial College London W2 1NY; n.shaikh@imperial.ac.uk; +44 (0)20 7594 9484), ref: 20SM6003

Study design

Retrospective analysis of routinely collected clinical data

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

No participant information sheet available

Condition

Paediatric emergency department presentation

Intervention

This study will involve retrospective analysis of routinely collected clinical data of all children presenting to emergency departments across Europe over a 2 and half year period. Aggregated, anonymous data will be entered on a monthly basis for each individual participating centre during the period spanning the COVID-19 pandemic (beginning February 2020). All data will be extracted from electronic health care records by the local clinical teams. Monthly aggregated data will be entered on a validated and secure online platform (RedCap). Aggregated, anonymous data will be presented on a weekly basis where each month or each week period will start at the first Monday (00:00 am) of that time period, through to the last Sunday (11:59 pm) of that time period. The total time period of interest will be January 1st, 2018 to May 1st, 2020 to allow for collection of historical data (prior to February 2020) for comparison. Once the data is collected it will be analysed after the end of the period of interest.

A quota sampling design will be used to select from which 1-4 institutions from each participating European countries data will be collected. Every site lead will complete a site-specific survey to inform on hospital-specific factors and local changes to healthcare pathways induced by the SARS-CoV-2 pandemic. No data with personal identifiable data will be collected, nor any data on patient individual level. Data will be analysed by comparing absolute numbers and percentages of children presenting to emergency departments, the severity of their presenting problems, their working diagnoses, and the patient outcomes, over time during the study period.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Absolute numbers of children presenting to the paediatric emergency department over the period of interest; for all children and children with different typologies (i.e. working diagnosis, age)

Secondary outcome measures

1. The severity of illness of children presenting to the paediatric emergency department over the period of interest as defined by the following criteria: percentage of children with abnormal vital parameters; high triage urgency; a composite outcome of the need for emergency medications, the need for hospital admission for >24 h, the need for PICU admission, and death
2. Change of relative incidence of children with specific diagnoses of interest and the severity of their presentation as a proxy for timeliness of presentations. Calculated from: absolute numbers of children presenting to the paediatric emergency department; the percentage of children with abnormal vital parameters; the number of cases with high triage urgency; a composite outcome of the need for emergency medications, the need for hospital admission for >24 h, the need for PICU admission, and death; over the period of interest and over an equivalent historical time period for comparison

Overall trial start date

14/06/2020

Overall trial end date

31/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. All children presenting to the emergency department during the period of interest for unscheduled health care
2. Aged between 0 and 18 years (upper age limit determined by the upper age bracket for children being assessed at the local participating centre)
3. Undergo a formal clinical assessment by advanced nurse practitioner (or equivalent) or clinician in the emergency department
4. All or part of the data of the triaging process (including vital signs), consultation, management (including diagnostics and treatment) and outcomes (including working diagnosis and disposition) routinely documented in the electronic patient record

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Between 6,000 and 60,000 per participating centre, 40 confirmed participating centres at the time of submission

Participant exclusion criteria

1. Children visiting the emergency department who are then streamed to a primary care service for the initial consultation.
2. Children presenting to the emergency department for scheduled health care or a planned follow-up visit (children who have an unscheduled re-visit to the emergency department within one disease episode are not excluded)

Recruitment start date

01/01/2018

Recruitment end date

14/05/2020

Locations

Countries of recruitment

France, Hungary, Italy, Malta, Netherlands, Spain, United Kingdom

Trial participating centre

Imperial College
London
W2 1NY
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Joint Research Compliance Office
Medical School building
Room 221
Norfolk Place
London
W211PG
United Kingdom
+44 (0)207 594 9465
cheuk-fung.wong@imperial.ac.uk

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Expect to publication of the main manuscript in a leading international peer-reviewed journal and presentation at international conferences. Anticipated production of short papers on both difficulties on harmonising routinely collected clinical data from European paediatric emergency departments, and changes in health care pathways across Europe amongst participants of the EPISODES study. Secondary analysis of the data may be performed with the approval of the EPISODES steering group after review of a study proposal by any member of the EPISODES study group. Furthermore, the EPISODES study will position the trial group in a unique position to respond rapidly to a potential second wave of Sars-Cov-2 infections and to collect data on epidemiological issues in paediatric emergency medicine.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from r.nijman@imperial.ac.uk. Requests and study proposals will be reviewed by the steering committee. Any of the data needed for any (approved by the steering committee) proposed analysis will be shared. These data will not contain patient individual data and are only available in aggregated and fully anonymised form. UK HRA approval was obtained; no patient informed consent was needed. Data will become available after acceptance of first publication of the main study results. Data will be available for 10 years after study closure.

Intention to publish date

01/10/2020

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/07/2020: Internal review. 14/07/2020: Trial’s existence confirmed by HRA and Health and Care Research Wales (HCRW).