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Recruiting NCT05898529

COVID Infection in Pediatric Surgical Patient

Observational COVID-19

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rapid antigen test.
Who it may be relevant to
Registry conditions: COVID-19. Basic parameters: 2 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prevalence of Asymptomatic COVID-19 Infection in Pediatric Surgical Patients

Overview

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

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.

Interventions

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

Primary outcome measures

  • Antigen test positive result [Time frame: 1 day]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Salem Anaesthesia Pain Clinic — Surrey

Identifiers

NCT: NCT05898529 · SalemAnes2023 Paed COVID Afr

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗