COVID Infection in Pediatric Surgical Patient

NCT ID: NCT05898529

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-12-31

Brief Summary

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Children infected with COVID-19 are mostly asymptomatic. There is a dearth of data on the epidemiology of COVID-19 in the pediatric population. This is a prospective observational clinical study of pediatric surgical patients. COVID-19 rapid antigen testing will be performed on pediatric patients.

Detailed Description

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Children infected with COVID-19 are mostly asymptomatic or mildly symptomatic. Children may spread COVID-19 to the elderly, vulnerable patients and medical staff. There is a dearth of data on the epidemiology of COVID-19 in the pediatric surgical population. Rapid antigen detection tests for the diagnosis of COVID-19 are reliable, simple, fast, and inexpensive.

This is a prospective observational clinical study. The study population will include all consenting pediatric surgical patients, aged 2-17 years. Informed consent will be obtained from each patient and the legal guardian who agree to participate in the study. Nasopharyngeal swab specimens will be collected from anesthetized pediatric patients. COVID-19 rapid antigen testing will be performed according to the equipment manufacturer's instructions.

Data collection will include COVID-19 test result, nasal swab complication, patient demographics, surgical history, medical history, regular medications, COVID-19 symptoms, and COVID-19 exposure information. COVID-19 symptoms that will be recorded are cough, wheeze, nasal congestion, breathing difficulty, new loss of taste or smell, fever, chills, rigors, body aches, sore throat, nausea, and fatigue. COVID-19 exposure will be considered as being within 6 feet of a person with diagnosed COVID-19 infection in the previous 14 days.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Rapid antigen test

COVID-19 rapid antigen testing of nasal swab

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* surgical patients aged 2-17 years
* informed consent for surgery
* no COVID-19 diagnosis in previous 6 months
* no history of nasal bleeding
* no history of coagulopathy.

Exclusion Criteria

* patient refusal of testing
* difficulty in obtaining consent
* COVID-19 diagnosis in recent 6 month
* history of nasal bleeding
* history of coagulopathy.
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Salem Anaesthesia Pain Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olumuyiwa Bamgbade

Role: PRINCIPAL_INVESTIGATOR

Salem Anaesthesia Pain Clinic

Locations

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Salem Anaesthesia Pain Clinic

Surrey, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Olumuyiwa Bamgbade, MD,FRCPC

Role: CONTACT

17786286600

Facility Contacts

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Olu Bamgbade, MD,FRCPC

Role: primary

+17786286600

Other Identifiers

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SalemAnes2023 Paed COVID Afr

Identifier Type: -

Identifier Source: org_study_id

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