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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06294977
Other study ID # CRISI-COVID
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 30, 2022
Est. completion date December 30, 2022

Study information

Verified date March 2024
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background. Seizures are a common cause of evaluation in the pediatric emergency department (ED). Several studies about the impact of COVID-19 pandemic on ED attendances report a considerable reduction in general pediatric care. The aim of our study was to evaluate the impact of COVID-19 on the admission to the pediatric ED for seizures. Materials and methods. We performed a retrospective study to assess the rate of ED admission for seizures at the pediatric ED of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milan between January 2017 and December 2021, comparing the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021).


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers
Gender All
Age group 1 Month to 17 Years
Eligibility Inclusion Criteria: - age: 1 months to 17 years - sex: all - with at least one access to the Pediatric ED of the hospital for seizures Exclusion Criteria: - children who received a diagnosis of seizure on admission in triage that was not confirmed at discharge (breath-holding spell, fainting…).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico Milan

Sponsors (1)

Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary During the study period, 1,091 patients with seizures were admitted to pediatric ED, 776 before the pandemic and 315 during the pandemic. In particular, the evaluation rates per month were 20.4 before the pandemic and 14.3 afterward the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021)
Secondary Patients with a history of previous seizures showed a greater decrease in the monthly number of ED visits compared to those with a first seizure. An increased rate of unprovoked seizures and a decreased rate of provoked ones were observed in the pandemic the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021)
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