COVID Infection in Pediatric Surgical Patient

Sponsor

Salem Anaesthesia Pain Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05898529

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

49.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Diagnostic Test: Rapid antigen test

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prevalence of Asymptomatic COVID-19 Infection in Pediatric Surgical Patients

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

Antigen test positive result [1 day]
COVID-19 antigen test positive

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Salem Anaesthesia Pain Clinic	Surrey	British Columbia	Canada	V3S 7J1

Sponsors and Collaborators

Salem Anaesthesia Pain Clinic

Investigators

Principal Investigator: Olumuyiwa Bamgbade, Salem Anaesthesia Pain Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Salem Anaesthesia Pain Clinic

ClinicalTrials.gov Identifier:

NCT05898529

Other Study ID Numbers:

SalemAnes2023 Paed COVID Nigr

First Posted:

Jun 12, 2023

Last Update Posted:

Jun 12, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jun 12, 2023