Prevalence of Covid-19 in Children Admitted to Paediatric... | NCT04336761

Studies
Prevalence of Covid-19 in Children Admitted to Paediatric Emergency Departments During the Pandemic Period in France

NCT04336761

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Mar 11, 2021Actual

Enrollment

901Actual

Phase

Not provided

Conditions

Coronavirus
COVID
Infection Viral

Interventions

nasopharyngeal swab

Countries

France

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

ID	Type	Description	Link
2020-A00811-38	Other Identifier	ID-RCB number,ANSM

Status Module

Record Verification Date

Mar 2021

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

Apr 15, 2020Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Jan 1, 2021Actual

First Submitted Date

Apr 3, 2020

First Submission Date that Met QC Criteria

Apr 3, 2020

First Posted Date

Apr 7, 2020Actual

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

Mar 10, 2021

Last Update Posted Date

Mar 11, 2021Actual

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

Arriving in December 2019, Coronavirus COVID-19 infection is causing a global pandemic with high morbidity and mortality among adults and especially seniors. The child appears little or no affected by this infection. It is estimated that the child could be asymptomatic or pauci-symptomatic carrier and thus be vector of the disease. For this reason, measures have been taken to close schools and contain populations in a large number of countries, including France. However, there are no data on the prevalence of COVID-19 in children.

Detailed Description

Not provided

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

Retention

Enrollment

901Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Child suspected of infection with COVID-19.		Child included with positive included	Diagnostic Test: nasopharyngeal swab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nasopharyngeal swab	Diagnostic Test	Data collection and nasopharyngeal swab	Child suspected of infection with COVID-19.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of positivity of COVID-19 virus measured by rt-PCR		At 28 days

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of positivity of COVID-19 virus measured by rt-PCR in the following subpopulations of emergency patients	children admitted to pediatric emergencies for respiratory signs Children hospitalized as a result of travelling to pediatric emergency departments for respiratory signs Respiratory asymptomatic children admitted to pediatric emergencies	at the end an average 28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1st Line Consultation in Pediatric Emergencies
All reasons for consultation during working hours
Informed and written consent of a parent holder (only 1 authorized companion) and a child of understanding age

Exclusion Criteria:

Refusal of participation by parents/child of decision age
No membership of a social security scheme (beneficiary or entitled)
No understanding of French

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children admitted to hospital pediatric emergencies in France during the pandemic period.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François Dubos, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CH Louis MOURIER		Colombes			France
Hôpital Jeanne de Flandres, CHU

Condition Browse Module

MeSH Terms

ID	Term
D018352	Coronavirus Infections
D014777	Virus Diseases

Ancestor Terms

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided