Investigating the impact of the coronavirus (COVID-19) pandemic on children presenting to emergency departments across Europe

Plain English summary of protocol

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 December 2021

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

Study website

Contact information

Dr Ruud Nijman
Scientific

St Marys Campus, Medical School Building
Room 235
Norfolk Place
London
W2 1PG
United Kingdom

ORCID ID	0000-0001-9671-8161
Phone	+44 (0)7442360730
Email	r.nijman@imperial.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• Austria
• England
• France
• Germany
• Hungary
• Iceland
• Ireland
• Italy
• Latvia
• Lithuania
• Malta
• Netherlands
• Portugal
• Slovenia
• Spain
• Sweden
• Türkiye
• United Kingdom

Study participating centres

Sponsor information

Imperial College London
University/education

Joint Research Compliance Office
Medical School building, Room 221
Norfolk Place
London
W211PG
England
United Kingdom

Phone	+44 (0)207 594 9465
Email	cheuk-fung.wong@imperial.ac.uk
Website	http://www3.imperial.ac.uk/
"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Other

Results and Publications

Study outputs

Additional files

ISRCTN91495258_Protocol_v3.0_13May2020.pdf

Editorial Notes

03/09/2024: Publication reference and study protocol (not peer-reviewed) added.
30/08/2022: Publication reference added.
01/04/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 14/05/2020 to 01/05/2021.
2. The overall trial end date was changed from 31/10/2020 to 31/12/2021.
3. The intention to publish date was changed from 01/10/2020 to 01/06/2021.
4. The interventions and publication and dissemination plan were updated.
26/03/2021: The trial participating centres have been added.
16/03/2021: Internal review.
15/07/2020: Internal review.
14/07/2020: Trial’s existence confirmed by HRA and Health and Care Research Wales (HCRW).