COVID Infection in Pediatric Surgical Patient

October 14, 2023 updated by: Salem Anaesthesia Pain Clinic

Prevalence of Asymptomatic COVID-19 Infection in Pediatric Surgical Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3S 7J1
        • Recruiting
        • Salem Anaesthesia Pain Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Consecutive surgical patients, aged 2-17 years.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antigen test positive result
Time Frame: 1 day
COVID-19 antigen test positive
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salem Anaesthesia Pain Clinic

Investigators

  • Principal Investigator: Olumuyiwa Bamgbade, Salem Anaesthesia Pain Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

June 9, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 14, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SalemAnes2023 Paed COVID Afr

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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