Recruiting

Breath AnalyzerVocxi Breath Analyzer Study in Pediatric Respiratory Infection

Sponsor:

University of Minnesota

Code:

NCT07902115

Conditions

Acute Respiratory Illness

Viral Respiratory Infection

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Accepted

Interventions

MBP® Breath Analyzer

Study Details

Brief 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.

Conditions

Acute Respiratory Illness

Viral Respiratory Infection

Study ID

NCT07902115

Start date

Oct 27, 2026

Status verified date

Oct, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Acute Respiratory Illness Group

Pediatric participants aged 7 to 17 years with signs or symptoms of acute respiratory illness will provide a breath sample using the MBP® Breath Analyzer. Acute respiratory illness is defined as two or more of the following: fever, cough, runny nose, nasal congestion, or sore throat.

experimental: Healthy Control Group

Pediatric participants aged 7 to 17 years presenting to the Emergency Department for minor injuries and without current or recent acute respiratory illness symptoms will provide a breath sample using the MBP® Breath Analyzer.

Interventions

MBP® Breath Analyzer

The MBP® Breath Analyzer is a handheld breath sensor connected to a secure dedicated study mobile phone with the Vocxi app. A mask is connected to the device, and the participant breathes normally into the mask for approximately 1 minute. The system collects volatile organic compound signal data from exhaled breath for research analysis. The device will not be used to diagnose, treat, or guide clinical care.

Primary outcome measure

Successful Breath Sample Collection Using the MBP® Breath Analyzer [ Time Frame: During the study visit, approximately 45 minutes ]
Measurable VOC Signals From Pediatric Breath Samples [ Time Frame: During the study visit, approximately 45 minutes ]

Central Contacts and Locations

Central contacts

Gwenyth Fischer

612-625-6678 fisch662@umn.edu

Locations

University of Minnesota Masonic Children's Hospital Pediatric Emergency Department

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Gwenyth Fischer

612-625-6678 fisch662@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Keywords

MBP Breath Analyzer
Volatile organic compounds
VOC
ARI
Upper respiratory infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.