EpilepsyNCT06294977
Impact of COVID-19 Pandemic on Epilepsy Evaluations in the Pediatric Emergency Department
An observational study of Epilepsy and Emergency Services, Hospital, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Epilepsy, Emergency Services, Hospital, COVID-19
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 30 Nov 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- Child
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
Who may be able to join
- age: 1 months to 17 years
- sex: all
- with at least one access to the Pediatric ED of the hospital for seizures
Who cannot join
- children who received a diagnosis of seizure on admission in triage that was not confirmed at discharge (breath-holding spell, fainting…).
Trial locations and contacts
1 site in 1 country.
Italy1 site
Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan
About this study
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).
- Conditions
- Epilepsy, Emergency Services, Hospital, COVID-19
- Medical subject headings
- Epilepsy, Emergencies, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start30 Nov 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Cappellari, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294977
- Sponsor's protocol ID
- CRISI-COVID
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 Pandemic on Epilepsy Evaluations in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT06294977
- Acronym / sponsor ID
- CRISI-COVID
- Conditions
- Epilepsy, Emergency Services, Hospital, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- age: 1 months to 17 years
- sex: all
- with at least one access to the Pediatric ED of the hospital for seizures
Key exclusion criteria (1 listed)
- children who received a diagnosis of seizure on admission in triage that was not confirmed at discharge (breath-holding spell, fainting…).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021)
1 secondary outcome
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
Time frame: the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Emergency Services, Hospital, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.