COVID-19 Clinical Trial
Official title:
Impact of COVID-19 Pandemic on Headache Evaluations in the Pediatric Emergency Department
| NCT number | NCT06295003 |
| Other study ID # | CEFA-COVID |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 30, 2022 |
| Est. completion date | May 30, 2022 |
| Verified date | March 2024 |
| Source | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 700 |
| Est. completion date | May 30, 2022 |
| Est. primary completion date | May 30, 2022 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 2 Years to 18 Years |
| Eligibility | Inclusion Criteria: - range of age: 2 - 18 years - sex: all - headache as main symptom Exclusion Criteria: - headache in the context of head trauma, because of different diagnostic-care in Pediatric Emergency Department |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Milan |
| Lead Sponsor | Collaborator |
|---|---|
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020). | ||
| Secondary | 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 | the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020). |
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