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NCT05898529 | RECRUITING | COVID-19


COVID Infection in Pediatric Surgical Patient
Sponsor:

Salem Anaesthesia Pain Clinic

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

COVID-19

Intervention/treatment

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 Type : OBSERVATIONAL
Estimated Enrollment : 350 participants
Official Title : Prevalence of Asymptomatic COVID-19 Infection in Pediatric Surgical Patients
Actual Study Start Date : 2023-07-01
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 2 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.

COVID Infection in Pediatric Surgical Patient

Location Details

NCT05898529


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Locations


RECRUITING

Canada, British Columbia

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, Canada, V3s 7j1

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