ClinicalTrials.gg
Not yet recruitingNCT07816822Updated Sep 14, 2026

PRAE and Asymptomatic and Symptomatic URI Patients

An observational study in Upper Respiratory Infection, Pediatric Surgical Patients and Perioperative Respiratory Adverse Events, sponsored by Brittany Willer. Not yet recruiting. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Brittany Willer · Observational

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
0 Years to 18 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Upper Respiratory Infection
  • Pediatric Surgical Patients
  • Perioperative Respiratory Adverse Events

Keywords

  • Asymptomatic URI
  • Symptomatic URI
  • PRAE
03

In context

Respiratory Tract Infections

753 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.

This study's planned enrollment of 300 is below the median of 350 across 184 observational studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

Brittany Willer is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Chronic medical problems (excluding asthma), diagnosis of cancer, transplant recipient, receiving immunomodulatory medications (cyclosporine, tacrolimus, azathioprine, mycophenolate, monoclonal AB, lithium), or currently prescribed antibiotics.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Recent URI patients

    Pediatric patients who report recent (within two weeks) or current URI symptoms presenting for surgery

    Diagnostic Test: Mid-turbinate nasal swab

  • Healthy pediatric patients

    Healthy pediatric patients without respiratory symptoms scheduled for surgery

    Diagnostic Test: Mid-turbinate nasal swab

Interventions

  • Diagnostic testMid-turbinate nasal swab

    Mid-turbinate nasal swab for viral testing using a PCR film array test (qRT-PCR).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Time of enrollment to time of hospital discharge, no more than 24 hours.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Dec 2029, 39 months later.

Of 66 non-industry observational studies under Respiratory Tract Infections, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 39 months is above that.

Counting every sponsor, half of 85 studies reached it within 18 months; a quarter within 8 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2026
First posted
Sep 14, 2026
StartEst.
Sep 2026
Primary completionEst.
Dec 2029
CompletionEst.
Dec 2029
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07816822
Lead sponsor
Brittany Willer
Responsible party
Brittany Willer (Pediatric Anesthesiologist, Nationwide Children's Hospital) — Sponsor-investigator
First posted
Sep 14, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2029 (estimated)
Completion
Dec 2029 (estimated)
Last update
Sep 14, 2026

Study contacts

Catherine Roth
Contact
catherine.roth@nationwidechildrens.org
614-722-2997
Brittany Willer, MD
principal investigator · Nationwide Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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