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Recruiting

NCT Number: NCT05898529

COVID Infection in Pediatric Surgical Patient

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.

Recruiting

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Key information

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, V3S 7J1, Canada

Location status: Recruiting

Location contact

Olu Bamgbade, MD,FRCPC

CONTACT

[email protected]

+17786286600

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rapid antigen test

Diagnostic Test

COVID-19 rapid antigen testing of nasal swab

Primary outcomes

  1. Antigen test positive result

    Time frame: 1 day

    COVID-19 antigen test positive

Study contacts

Contact information is provided by the study sponsor or research team.

Olumuyiwa Bamgbade, MD,FRCPC

CONTACT

[email protected]

17786286600

Sponsors and collaborators

Lead sponsor

Salem Anaesthesia Pain Clinic

Other

Registry information

Official study title

Prevalence of Asymptomatic COVID-19 Infection in Pediatric Surgical Patients

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2023
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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