Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
240 participants
OBSERVATIONAL
2019-11-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Wheezing 3~11months
Patient has wheezing, age 3 to 11 months
No interventions assigned to this group
Wheezing 12~23months
Patient has wheezing, age 12 to 23 months
No interventions assigned to this group
Wheezing 24~35months
Patient has wheezing, age 24 to 35 months
No interventions assigned to this group
Wheezing 36~107months
Patient has wheezing, age 36 to 107 months
No interventions assigned to this group
No wheezing 3~11months
Patient do not have wheezing, age 3 to 11 months
No interventions assigned to this group
No wheezing 12~23months
Patient do not have wheezing, age 12 to 23 months
No interventions assigned to this group
No wheezing 24~35months
Patient do not have wheezing, age 24 to 35 months
No interventions assigned to this group
No wheezing 36~107months
Patient do not have wheezing, age 36 to 107 months
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Does the subject have mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis?
2. Is the subject between the ages of 3 months to 8 years old?
3. Is the parent or legal guardian available, and capable and willing to give a consent on the child's behalf.
Exclusion Criteria
1. Does the subject have skin rashes or wounds on the chest?
2. Does the subject have known allergies or irritant contact dermatitis or having hypersensitive skin?
3. Does the subject have a defibrillator and/or pacemaker (which could interfere with the sounds to be detected)?
4. Does the subject have an allergy to disinfecting alcohol?
5. Does the subject have wheezes caused by not asthma, such as reflux esophagitis, pneumonia, vocal cord dysfunction, Tracheomatosis?
6. Does the subject have a heavy runny nose?
7. Is it difficult to hear auscultation due to the subject fussing, crying or vocalizing at data collection?
8. Is the subject having difficulty breathing or having severe symptoms?
9. Was the subject enrolled more than once for the same resulted breath sounds?
* Note: The subject maybe enrolled once per arm (once wheezing, once non-wheezing).
3 Months
8 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
University of Chicago
OTHER
Omron Healthcare Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Tekton Research
Chamblee, Georgia, United States
University of Chicago
Chicago, Illinois, United States
PMG Research of DuPage
Joliet, Illinois, United States
Long Island Jewish Medical Center
New York, New York, United States
PMG Research of Raleigh
Raleigh, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Children's Hospital Medical Center
Cincinnati, Ohio, United States
PMG Research of Charleston
Charleston, South Carolina, United States
Meridian Clinical Research, LLC
Dakota Dunes, South Dakota, United States
PMG Research of Bristol
Bristol, Tennessee, United States
PMG Research of Knoxville
Jefferson City, Tennessee, United States
Tekton Research
Beaumont, Texas, United States
Tekton Research
San Antonio, Texas, United States
Tekton Research
San Antonio, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Brenda Louise Giles, MD
Role: primary
Maria Santiago, MD
Role: primary
William Stewart, MD
Role: primary
Rachelle Ramsey, MD
Role: primary
Sophie Kollin
Role: backup
Robert Bell, MD
Role: primary
Kenneth Etokhana, MD
Role: primary
Manish N Shah, MD, MPH
Role: primary
Other Identifiers
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HDV-CDD-190046
Identifier Type: -
Identifier Source: org_study_id
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