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NCT06295003 Clinical Trial

Impact of COVID-19 Pandemic on Headache Evaluations in the Pediatric Emergency Department

COVID-19 Clinical Trial

Official title:
Impact of COVID-19 Pandemic on Headache Evaluations in the Pediatric Emergency Department

Clinical Trial Details — Status: Completed

Administrative data
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

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: 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).

Recruitment information / eligibility
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

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, 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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