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NCT05898529 Clinical Trial

COVID Infection in Pediatric Surgical Patient

COVID-19 Clinical Trial

Official title:
Prevalence of Asymptomatic COVID-19 Infection in Pediatric Surgical Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05898529
Other study ID # SalemAnes2023 Paed COVID Afr
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date May 31, 2024

Study information
Verified date October 2023
Source Salem Anaesthesia Pain Clinic
Contact Olumuyiwa Bamgbade, MD,FRCPC
Phone 17786286600
Email olu.bamgbade@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 17 Years
Eligibility Inclusion Criteria: - surgical patients aged 2-17 years - informed consent - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Rapid antigen test
COVID-19 rapid antigen testing of nasal swab

Locations
Country Name City State
Canada Salem Anaesthesia Pain Clinic Surrey British Columbia

Sponsors (1)
Lead Sponsor Collaborator
Salem Anaesthesia Pain Clinic

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Antigen test positive result COVID-19 antigen test positive 1 day
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