Status:
COMPLETED
Diagnosing Respiratory Disease in Children Using Cough Sounds 2
Lead Sponsor:
ResApp Health Limited
Collaborating Sponsors:
Massachusetts General Hospital
The Cleveland Clinic
Conditions:
Pneumonia
Bronchiolitis
Eligibility:
All Genders
29-12 years
Brief Summary
The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software application in the diagnosis of childhood acute respiratory disease, including pneumonia, bronchiolitis, asth...
Eligibility Criteria
Inclusion
- Infant or child aged greater than 29 days up to and including their 12th birthday (infant and children pediatric subgroups as defined in Guidance for Industry and Food and Drug Administration Staff: Premarket Assessment of Pediatric Medical Devices dated March 24, 2014)
- Presenting to the study site (an outpatient facility, an urgent care center, an Emergency Department, or inpatient ward within 24 hours of admission) with current signs or symptoms of respiratory disease including cough, wheezing, stridor, chest in-drawing/retractions, difficulty breathing, fast breathing, nasal congestion/rhinorrhea, abnormal lung sounds on exam or cyanosis/hypoxemia.
- Onset of symptoms within past 14 days
- Outpatient or inpatient within 24 hours of admission
- Coughing spontaneously or able to cough voluntarily
Exclusion
- Lack of a signed consent form from parent or legal guardian
- Lack of signed assent form for children aged 7 years or older who, in the opinion of the investigator, is able to provide assent based on their age, maturity or psychological state.
- Need for mechanical ventilatory support ((including invasive, CPAP, or BiPAP)) or high flow nasal cannula
- History of structural airways abnormalities, tracheobronchomalacia, or vocal cord abnormalities (e.g. laryngomalacia, tracheomalacia, or bronchomalacia)
- Any medical contraindication to voluntary cough, including the following (only enroll if coughing spontaneously): severe respiratory distress, history of pneumothorax, eye/chest/abdominal surgery in past 3 months, hemoptysis in the past month
- Too medically unstable to participate in study per treating clinician
- Subject previously enrolled in SMARTCOUGH-C-2 study
- Tracheostomy present or tube placed
Key Trial Info
Start Date :
January 5 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 19 2018
Estimated Enrollment :
1470 Patients enrolled
Trial Details
Trial ID
NCT03392363
Start Date
January 5 2018
End Date
October 19 2018
Last Update
November 8 2018
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Cleveland Clinic Children's
Cleveland, Ohio, United States, 44195
3
Texas Children's Hospital
Houston, Texas, United States, 77030