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

Sponsor
University Hospital, Lille (Other)
Overall Status
Completed
CT.gov ID
NCT04336761
Collaborator
(none)
901
6
8.6
150.2
17.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: nasopharyngeal swab

Study Design

Study Type:
Observational
Actual Enrollment :
901 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevalence of Covid-19 in Children Admitted to Paediatric Emergency Departments During the Pandemic Period in France
Actual Study Start Date :
Apr 15, 2020
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Child suspected of infection with COVID-19.

Child included with positive included

Diagnostic Test: nasopharyngeal swab
Data collection and nasopharyngeal swab

Outcome Measures

Primary Outcome Measures

  1. Prevalence of positivity of COVID-19 virus measured by rt-PCR [At 28 days]

Secondary Outcome Measures

  1. Prevalence of positivity of COVID-19 virus measured by rt-PCR in the following subpopulations of emergency patients [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

  2. Respiratory signs of children tested within 28 day [through study completion, an average 28 days]

  3. Percentage of children hospitalized tested within 28 day [through study completion, an average 28 days]

  4. Contact frequency [At inclusion]

    the degree of relationship with these contacts and the time spent in contact with them within 24 hours before emergency

  5. Prevalence of positivity of other respiratory viruses measured by rt-PCR [at 28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CH Louis MOURIER Colombes France
2 Hôpital Jeanne de Flandres, CHU Lille France 59037
3 Hôpital Mère Enfant CHU Nantes France
4 Hôpitaux Pédiatriques de Nice CHU-Lenval Nice France
5 Hôpital des enfants - CHU Toulouse France
6 CHU de Tours Tours France

Sponsors and Collaborators

  • University Hospital, Lille

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT04336761
Other Study ID Numbers:
  • 2020_21
  • 2020-A00811-38
First Posted:
Apr 7, 2020
Last Update Posted:
Mar 11, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Lille
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2021