NCT06294977

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

March 4, 2024

Last Update Submit

March 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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)

Eligibility Criteria

Age1 Month - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

All children under the age of 18 years who had at least one access to the Pediatric ED of the hospital for seizures

You may qualify if:

  • age: 1 months to 17 years
  • sex: all
  • with at least one access to the Pediatric ED of the hospital for seizures

You may not qualify if:

  • children who received a diagnosis of seizure on admission in triage that was not confirmed at discharge (breath-holding spell, fainting…).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, Italy

Location

MeSH Terms

Conditions

EpilepsyEmergenciesCOVID-19

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Princpal investigator

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 6, 2024

Study Start

November 30, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations