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CompletedNCT06295003Updated Mar 6, 2024

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

An observational study in COVID-19, Headache Disorders and Emergency Service, Hospital, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Completed at 1 site in Italy. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
700
Ages
2 Years to 18 Years
Sex
All
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Study 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).

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Conditions studied

  • COVID-19
  • Headache Disorders
  • Emergency Service, Hospital
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 700 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 214 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

patients aged 2-18 years evaluated in Pediatric Emergency Department because of headache as main symptom

Inclusion criteria

  • range of age: 2 - 18 years
  • sex: all
  • headache as main symptom

Exclusion criteria

Exclusion Criteria:

  • headache in the context of head trauma, because of different diagnostic-care in Pediatric Emergency Department
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
700 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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).

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

    Time frame: the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020).

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Study locations

1 site
  • Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico
    Milan, Italy
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06295003
Lead sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Responsible party
Alberto Cappellari (Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico) — Principal investigator
First posted
Mar 6, 2024
Start date
Apr 30, 2022
Primary completion
May 30, 2022
Completion
May 30, 2022
Last update
Mar 6, 2024
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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