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NCT07902115
Vocxi Breath Analyzer Study in Pediatric Respiratory Infection
Conditions: Acute Respiratory Illness, Viral Respiratory Infection
Sex: All
Ages: 7 Years – 17 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 20
Sponsor: University of Minnesota
Location: University of Minnesota Masonic Children's Hospital Pediatric Emergency Department Minneapolis Minnesota
Summary
This pilot study will evaluate whether the MBP® Breath Analyzer can collect measurable volatile organic compound signals from pediatric participants with acute respiratory illness and from healthy pediatric controls.
Children aged 7 to 17 years presenting to the Masonic Children's Hospital Pediatric Emergency Department will be enrolled. One group will include participants with signs or symptoms of acute respiratory illness, and the control group will include participants presenting for minor injuries without respiratory symptoms.
Participants will breathe normally into the MBP® Breath Analyzer for approximately 1 minute. VOC signal data will be analyzed to assess device performance and to explore whether breath VOC patterns differ between pediatric participants with respiratory infection and healthy controls.
Eligibility Criteria
Inclusion Criteria for Acute Respiratory Illness Group::
* Age 7 to 17 years
* Able to participate in study procedures, including breathing comfortably into the MBP® Breath Analyzer for 1 minute
* Meets the case definition of acute respiratory illness, defined as two or more of the following signs or symptoms: fever, cough, runny nose, nasal congestion, or sore throat
Inclusion Criteria for Control Group:
* Age 7 to 17 years
* Able to participate in study procedures, including breathing comfortably into the MBP® Breath Analyzer for 1 minute
* Does not have symptoms of acute respiratory illness
* Has not had symptoms of acute respiratory illness within the past month by parent or patient report
* Being seen in the Emergency Department for a minor injury, such as ankle sprain or laceration, with plan to discharge from the Emergency Department
Exclusion Criteria:
* Unable to comfortably breathe normally into the MBP® Breath Analyzer for 1 minute
* Has eaten in the 30 minutes prior to use
* Has smoked in the 2 hours prior to use
* Primary diagnosis or parent concern in the Emergency Department is asthma or reactive airway disease
* History of or current cancer of any kind
* Current smoke inhalation injury
* Current concern for a drowning event
* Current concern for a drug overdose
* Requiring oxygen in the Emergency Department
* Current tracheostomy in place
* Non-English speaker
* Prisoner
* Active member of the military or DoD personnel
* Patient with research opt-out status in the medical record
* ESI score of 1 or 2
Source: ClinicalTrials.gov (NCT07902115). StuddyBuddy aggregates publicly available trial information.