Upper Respiratory InfectionNCT07816822
PRAE and Asymptomatic and Symptomatic URI Patients
An observational study of Upper Respiratory Infection and Pediatric Surgical Patients, run by Brittany Willer.
Trial summary
The objective of this study is to determine the prevalence of asymptomatic viral carriers among healthy surgical patients and to describe the demographic and clinical characteristics of these patients. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Upper Respiratory Infection, Pediatric Surgical Patients, Perioperative Respiratory Adverse Events
- What is being tested?
- Mid-turbinate nasal swab
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2029
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients <18 presenting at NCH for elective ambulatory procedures under general anesthesia. 100 patients who are asymptomatic for URI symptoms 200 patients who report recent (within 2 weeks) or current URI symptoms.
Who may be able to join
- Patients <18 years of age presenting for elective ambulatory procedures under general anesthesia at NCH. Patient will either identify as asymptomatic or have had URI symptoms currently or within the past two weeks.
Who cannot join
- Chronic medical problems (excluding asthma), diagnosis of cancer, transplant recipient, receiving immunomodulatory medications (cyclosporine, tacrolimus, azathioprine, mycophenolate, monoclonal AB, lithium), or currently prescribed antibiotics.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Incidence of PRAE on Asymptomatic and Symptomatic URI Surgical Patients
The objective of this study is to determine the prevalence of asymptomatic viral carriers among healthy surgical patients and to describe the demographic and clinical characteristics of these patients. The secondary objective is to compare the incidence of perioperative respiratory adverse events (PRAE) between virus positive patients with and without upper respiratory infection (URI) symptoms. The secondary objective would aim to enroll patients who report recent URI symptoms.
Read the detailed description
The primary endpoint is to determine the prevalence of asymptomatic viral carriers among healthy pediatric surgical patients and describe the demographic and clinical characteristics of these patients. This will be done using prospectively collected respiratory swabs from healthy asymptomatic children undergoing elective pediatric surgery. This will result in a quantifiably proportion of children who test positive for respiratory viruses. This aim will define the epidemiologic baseline of silent viral URIs in children undergoing elective surgery. We can then evaluate the association between asymptomatic viral infections and perioperative respiratory adverse events (PRAEs). A secondary endpoint will be to compare the incidence of PRAE between virus positive patients with and without URI symptoms. This will be done by prospectively enrolling patients who report recent (within 2 weeks) or current URI symptoms.
- Conditions
- Upper Respiratory Infection, Pediatric Surgical Patients, Perioperative Respiratory Adverse Events
- Being tested
- Mid-turbinate nasal swab
- Keywords
- Asymptomatic URI, Symptomatic URI, PRAE
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mid-turbinate nasal swabDiagnostic test
Mid-turbinate nasal swab for viral testing using a PCR film array test (qRT-PCR).
| Study group | Role | What they receive |
|---|---|---|
| Recent URI patients | Pediatric patients who report recent (within two weeks) or current URI symptoms presenting for surgery Receives: Diagnostic Test: Mid-turbinate nasal swab | |
| Healthy pediatric patients | Healthy pediatric patients without respiratory symptoms scheduled for surgery Receives: Diagnostic Test: Mid-turbinate nasal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result from mid-turbinate nasal swab to test of viruses that cause URI by qRT-PCR test.
All patients will be tested for the presence of viruses that cause upper respiratory infections by taking a mid-turbinate nasal swab and using a PCR film array test.
Measured: From enrollment to the end of the surgery, no more than 8 hours.
Secondary outcomes (1)
Association between asymptomatic viral infections and perioperative respiratory adverse events (PRAEs).
Occurrence of PRAE during or after surgery.
Measured: Time of enrollment to time of hospital discharge, no more than 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory InfectionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brittany Willer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brittany Willer, Nationwide Children's Hospital
- Investigators
- Brittany Willer, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816822
- Sponsor's protocol ID
- STUDY00005442
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of PRAE on Asymptomatic and Symptomatic URI Surgical Patients
- ClinicalTrials.gov ID
- NCT07816822
- Acronym / sponsor ID
- STUDY00005442
- Conditions
- Upper Respiratory Infection, Pediatric Surgical Patients, Perioperative Respiratory Adverse Events
- Keywords
- Asymptomatic URI, Symptomatic URI, PRAE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Brittany WillerUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 14 Sep 2026 (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.
The objective of this study is to determine the prevalence of asymptomatic viral carriers among healthy surgical patients and to describe the demographic and clinical characteristics of these patients. The secondary objective is to compare the incidence of perioperative respiratory adverse events (PRAE) between virus positive patients with and without upper respiratory infection (URI) symptoms. The secondary objective would aim to enroll patients who report recent URI symptoms.
Detailed description
The primary endpoint is to determine the prevalence of asymptomatic viral carriers among healthy pediatric surgical patients and describe the demographic and clinical characteristics of these patients. This will be done using prospectively collected respiratory swabs from healthy asymptomatic children undergoing elective pediatric surgery. This will result in a quantifiably proportion of children who test positive for respiratory viruses. This aim will define the epidemiologic baseline of silent viral URIs in children undergoing elective surgery. We can then evaluate the association between asymptomatic viral infections and perioperative respiratory adverse events (PRAEs). A secondary endpoint will be to compare the incidence of PRAE between virus positive patients with and without URI symptoms. This will be done by prospectively enrolling patients who report recent (within 2 weeks) or current URI symptoms.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recent URI patients | – | Diagnostic Test: Mid-turbinate nasal swabPediatric patients who report recent (within two weeks) or current URI symptoms presenting for surgery |
| Healthy pediatric patients | – | Diagnostic Test: Mid-turbinate nasal swabHealthy pediatric patients without respiratory symptoms scheduled for surgery |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients <18 presenting at NCH for elective ambulatory procedures under general anesthesia. 100 patients who are asymptomatic for URI symptoms 200 patients who report recent (within 2 weeks) or current URI symptoms.
Key inclusion criteria (1 listed)
- Patients <18 years of age presenting for elective ambulatory procedures under general anesthesia at NCH. Patient will either identify as asymptomatic or have had URI symptoms currently or within the past two weeks.
Key exclusion criteria (1 listed)
- Chronic medical problems (excluding asthma), diagnosis of cancer, transplant recipient, receiving immunomodulatory medications (cyclosporine, tacrolimus, azathioprine, mycophenolate, monoclonal AB, lithium), or currently prescribed antibiotics.
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 |
|---|---|---|
| Mid-turbinate nasal swabMid-turbinate nasal swab for viral testing using a PCR film array test (qRT-PCR). | Diagnostic test | Healthy pediatric patients, Recent URI patients |
Primary outcome
Result from mid-turbinate nasal swab to test of viruses that cause URI by qRT-PCR test.
Time frame: From enrollment to the end of the surgery, no more than 8 hours.
All patients will be tested for the presence of viruses that cause upper respiratory infections by taking a mid-turbinate nasal swab and using a PCR film array test.
1 secondary outcome
Association between asymptomatic viral infections and perioperative respiratory adverse events (PRAEs).
Time frame: Time of enrollment to time of hospital discharge, no more than 24 hours.
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 14 Sep 2026.
- 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.
Brittany Willer, MD principal investigator
Nationwide Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Respiratory Infection and Pediatric Surgical Patients, run by Brittany Willer.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Catherine Roth (614-722-2997, catherine.roth@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Result from mid-turbinate nasal swab to test of viruses that cause URI by qRT-PCR test. (time frame: From enrollment to the end of the surgery, no more than 8 hours.). 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 14 Sep 2026.