Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-28 @ 9:38 AM
Study NCT ID:
NCT04336761
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2020-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Covid-19 in Children Admitted to Paediatric Emergency Departments During the Pandemic Period in France
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Nasopharyngeal swab'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 901}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-10', 'studyFirstSubmitDate': '2020-04-03', 'studyFirstSubmitQcDate': '2020-04-03', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of positivity of COVID-19 virus measured by rt-PCR', 'timeFrame': 'At 28 days'}], 'secondaryOutcomes': [{'measure': 'Prevalence of positivity of COVID-19 virus measured by rt-PCR in the following subpopulations of emergency patients', 'timeFrame': 'at the end an average 28 days', 'description': 'children admitted to pediatric emergencies for respiratory signs\n\n* Children hospitalized as a result of travelling to pediatric emergency departments for respiratory signs\n* Respiratory asymptomatic children admitted to pediatric emergencies'}, {'measure': 'Respiratory signs of children tested within 28 day', 'timeFrame': 'through study completion, an average 28 days'}, {'measure': 'Percentage of children hospitalized tested within 28 day', 'timeFrame': 'through study completion, an average 28 days'}, {'measure': 'Contact frequency', 'timeFrame': 'At inclusion', 'description': 'the degree of relationship with these contacts and the time spent in contact with them within 24 hours before emergency'}, {'measure': 'Prevalence of positivity of other respiratory viruses measured by rt-PCR', 'timeFrame': 'at 28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric emergencies', 'pandemia'], 'conditions': ['Coronavirus', 'COVID', 'Infection Viral']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children admitted to hospital pediatric emergencies in France during the pandemic period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1st Line Consultation in Pediatric Emergencies\n* All reasons for consultation during working hours\n* Informed and written consent of a parent holder (only 1 authorized companion) and a child of understanding age\n\nExclusion Criteria:\n\n* Refusal of participation by parents/child of decision age\n* No membership of a social security scheme (beneficiary or entitled)\n* No understanding of French'}, 'identificationModule': {'nctId': 'NCT04336761', 'acronym': 'INCOVPED', 'briefTitle': 'Prevalence of Covid-19 in Children Admitted to Paediatric Emergency Departments During the Pandemic Period in France', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Prevalence of Covid-19 in Children Admitted to Paediatric Emergency Departments During the Pandemic Period in France', 'orgStudyIdInfo': {'id': '2020_21'}, 'secondaryIdInfos': [{'id': '2020-A00811-38', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Child suspected of infection with COVID-19.', 'description': 'Child included with positive included', 'interventionNames': ['Diagnostic Test: nasopharyngeal swab']}], 'interventions': [{'name': 'nasopharyngeal swab', 'type': 'DIAGNOSTIC_TEST', 'description': 'Data collection and nasopharyngeal swab', 'armGroupLabels': ['Child suspected of infection with COVID-19.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Colombes', 'country': 'France', 'facility': 'CH Louis MOURIER', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Jeanne de Flandres, CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Hôpital Mère Enfant CHU', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'country': 'France', 'facility': 'Hôpitaux Pédiatriques de Nice CHU-Lenval', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital des enfants - CHU', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'François Dubos, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}