COVID-19NCT06295003
Impact of COVID-19 Pandemic on Headache Evaluations in the Pediatric Emergency Department
An observational study of COVID-19 and Headache Disorders, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Background: To evaluate the impact of COVID-19 on evaluations in the pediatric emergency department (ED) because of headache as main symptom. Methods: Number and clinical features of patients evaluated in the pediatric ED of a single site in Milan,Italy, were collected between January 2017 and January 2022. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- COVID-19, Headache Disorders, Emergency Service, Hospital
- How many people
- 700 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2022to 30 May 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 2 to 18 years
- All sexes
- Child, Adult
Study population: patients aged 2-18 years evaluated in Pediatric Emergency Department because of headache as main symptom
Who may be able to join
- range of age: 2 - 18 years
- sex: all
- headache as main symptom
Who cannot join
- headache in the context of head trauma, because of different diagnostic-care in Pediatric Emergency Department
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: To evaluate the impact of COVID-19 on evaluations in the pediatric emergency department (ED) because of headache as main symptom.
Methods: Number and clinical features of patients evaluated in the pediatric ED of a single site in Milan,Italy, were collected between January 2017 and January 2022. The impact of COVID-19 on evaluation rates was quantified by using the incidence rate ratio (IRR) and 95% confidence intervals (CI) between the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020).
- Conditions
- COVID-19, Headache Disorders, Emergency Service, Hospital
- Medical subject headings
- COVID-19, Headache Disorders, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
During the study period, 890 evaluations were registered: the number of partecipants was 689 over the prepandemic period and 201 over the pandemic period. Mean age at evaluation was 10 years (range: 1 to 17 years).
Measured: the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020).
Secondary outcomes (1)
Evaluation rates per month were 18.1 during the prepandemic period and 8.7 during COVID-19 pandemic, with peaks in autumn and winter and drops in summer. The reduction in evaluation rate was higher for secondary headache when compared with primary one
Measured: the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020).
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 Apr 2022
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 700 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
- NCT06295003
- Sponsor's protocol ID
- CEFA-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 Headache Evaluations in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT06295003
- Acronym / sponsor ID
- CEFA-COVID
- Conditions
- COVID-19, Headache Disorders, Emergency Service, Hospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 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: To evaluate the impact of COVID-19 on evaluations in the pediatric emergency department (ED) because of headache as main symptom.
Methods: Number and clinical features of patients evaluated in the pediatric ED of a single site in Milan,Italy, were collected between January 2017 and January 2022. The impact of COVID-19 on evaluation rates was quantified by using the incidence rate ratio (IRR) and 95% confidence intervals (CI) between the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- patients aged 2-18 years evaluated in Pediatric Emergency Department because of headache as main symptom
Key inclusion criteria (3 listed)
- range of age: 2 - 18 years
- sex: all
- headache as main symptom
Key exclusion criteria (1 listed)
- headache in the context of head trauma, because of different diagnostic-care in Pediatric Emergency Department
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, 890 evaluations were registered: the number of partecipants was 689 over the prepandemic period and 201 over the pandemic period. Mean age at evaluation was 10 years (range: 1 to 17 years).
Time frame: the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020).
1 secondary outcome
Evaluation rates per month were 18.1 during the prepandemic period and 8.7 during COVID-19 pandemic, with peaks in autumn and winter and drops in summer. The reduction in evaluation rate was higher for secondary headache when compared with primary one
Time frame: the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020).
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 COVID-19 and Headache Disorders, 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, 890 evaluations were registered: the number of partecipants was 689 over the prepandemic period and 201 over the pandemic period. Mean age at evaluation was 10 years (range: 1 to 17 years). (time frame: the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020).). 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.