COVID-19NCT05898529
COVID Infection in Pediatric Surgical Patient
An observational study of COVID-19, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Rapid antigen test
- How many people
- 350 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Consecutive surgical patients, aged 2-17 years.
Who may be able to join
- 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.
Who cannot join
- patient refusal of testing
- difficulty in obtaining consent
- COVID-19 diagnosis in recent 6 month
- history of nasal bleeding
- history of coagulopathy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Salem Anaesthesia Pain Clinic
Surrey, British Columbia, V3S 7J1
Olu Bamgbade, MD,FRCPC, +17786286600, salem.painclinic@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Rapid antigen test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid antigen testDiagnostic test
COVID-19 rapid antigen testing of nasal swab
What is being measured
The primary outcome is the main question the study is designed to answer.
Antigen test positive result
COVID-19 antigen test positive
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salem Anaesthesia Pain Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olumuyiwa Bamgbade, Principal investigator, Salem Anaesthesia Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898529
- Sponsor's protocol ID
- SalemAnes2023 Paed COVID Afr
- Status last verified
- Jan 2025
- First submitted
- 9 Jun 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Asymptomatic COVID-19 Infection in Pediatric Surgical Patients
- ClinicalTrials.gov ID
- NCT05898529
- Acronym / sponsor ID
- SalemAnes2023 Paed COVID Afr
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Salem Anaesthesia Pain ClinicUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Consecutive surgical patients, aged 2-17 years.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- patient refusal of testing
- difficulty in obtaining consent
- COVID-19 diagnosis in recent 6 month
- history of nasal bleeding
- history of coagulopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid antigen testCOVID-19 rapid antigen testing of nasal swab | Diagnostic test | – |
Primary outcome
Antigen test positive result
Time frame: 1 day
COVID-19 antigen test positive
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olumuyiwa Bamgbade principal investigator
Salem Anaesthesia Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olumuyiwa Bamgbade, MD,FRCPC (17786286600, olu.bamgbade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antigen test positive result (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.