Impact of the Qatar 2022 FIFA World Cup on PED Use and Mi... | NCT05818215

Studies
Impact of the Qatar 2022 FIFA World Cup on PED Use and Misuse Patterns

NCT05818215

Sponsor

Pediatric Clinical Research Platform

Status

Completed

Last Update Posted

Apr 18, 2023Actual

Enrollment

18,000Actual

Phase

Not provided

Conditions

Emergencies
Epidemic Disease
Pediatric ALL
Electronic Medical Record

Interventions

NO intervention

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Jan 20, 2023Actual

Completion Date

Jan 20, 2023Actual

First Submitted Date

Apr 5, 2023

First Submission Date that Met QC Criteria

Apr 5, 2023

First Posted Date

Apr 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2023

Last Update Posted Date

Apr 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Johan Siebert, MD, Principal Investigator, Pediatric Clinical Research PlatformPrincipal Investigator

Lead Sponsor

Pediatric Clinical Research PlatformOTHER

Collaborators

Name	Class
University of Lausanne Hospitals	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A retrospective cohort study to explore the impact of the FIFA World Cup 2022 Qatar on paediatric emergency department attendance at two tertiary centres during unprecedent winter viral epidemics.

Detailed Description

Earlier studies have reported contradictory relationship between major sporting events and paediatric emergency department attendance. None were conducted during an epidemic surge. The FIFA football World Cup 2022 was held for the first time in its history during the winter period in the northern hemisphere during unprecedented cumulative waves of respiratory syncitial virus (RSV), influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemics.

This study aims to measure the impact of such a global major sporting events on the pattern of paediatric emergency department use and hospital admissions during a peak epidemic season in 2 tertiary hospitals. The study hypothesis was that major sporting events, even during an epidemic peak, can reduce the number of paediatric emergency department visits compared with periods without a sporting event. Major sporting events could serve as a model for identifying human behaviours and patterns leading to paediatric emergency department misuse, in order to develop public health interventions to better rationalise health-seeking behaviours.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

18,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All participants		Data from electronic medical records of all patients under 16 years of age with medical, surgical and traumatology emergencies attending the paediatric emergency departments during the study period	Other: NO intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NO intervention	Other	NO intervention	All participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PED visits	Retrospective analysis of number of PED visits (counts).	Institutional electronic medical records analysed retrospectively from October 1st, 2022 to December 31, 2022

Secondary Outcomes

Measure	Description	Time Frame
Triage acuity score	Retrospective analysis of number of PED visits (counts) by triage acuity score (coded using the 5-level Canadian Triage and Acuity Scale (from level 1 [resuscitation] to level 5 [nonurgent]).	Institutional electronic medical records analysed retrospectively from October 1st, 2022 to December 31, 2022

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

16 Years

Standard Ages

Child

Study Population

All patients under 16 years of age with medical, surgical and traumatology emergencies attending each pediatric emergency department during the study period will be included. This also includes transfer cases from other hospitals, as well as those who leave prematurely without being seen.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johan N Siebert, MD	Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Geneva Children's Hospital		Geneva			Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Individual Participant Data will be deidentified and the study investigators will house the data locally on secured servers at the Geneva University Hospitals. The datasets used or analysed during the current trial will be available from the corresponding author upon reasonable request. Only deidentified/anonymised data will be shared.

Types

Not provided

Time Frame

Available from 6 month to 5 years after trial publication.

Access Criteria

Data will be made available from the corresponding author upon approval of a proposal and with a signed data access agreement.
Data will be made available for a specified research purpose.
The request proposal must include a statistician.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D007251	Influenza, Human

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007945	Leukemia, Lymphoid

Browse Leaves

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Browse Branches

Not provided