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

March 10, 2021 updated by: University Hospital, Lille
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

901

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Colombes, France
        • CH Louis Mourier
      • Lille, France, 59037
        • Hôpital Jeanne de Flandres, CHU
      • Nantes, France
        • Hôpital Mère Enfant CHU
      • Nice, France
        • Hôpitaux Pédiatriques de Nice CHU-Lenval
      • Toulouse, France
        • Hôpital des enfants - CHU
      • Tours, France
        • CHU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Child suspected of infection with COVID-19.
Child included with positive included
Diagnostic test: nasopharyngeal swab
Data collection and nasopharyngeal swab

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of positivity of COVID-19 virus measured by rt-PCR in the following subpopulations of emergency patients
Time Frame: at the end an average 28 days

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
Respiratory signs of children tested within 28 day
Time Frame: through study completion, an average 28 days
through study completion, an average 28 days
Percentage of children hospitalized tested within 28 day
Time Frame: through study completion, an average 28 days
through study completion, an average 28 days
Contact frequency
Time Frame: At inclusion
the degree of relationship with these contacts and the time spent in contact with them within 24 hours before emergency
At inclusion
Prevalence of positivity of other respiratory viruses measured by rt-PCR
Time Frame: at 28 days
at 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: François Dubos, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2020

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 3, 2020

First Posted (Actual)

April 7, 2020

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_21
  • 2020-A00811-38 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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