Diagnosing Respiratory Disease in Children Using Cough Sounds 2 (SMARTCOUGH-C-2)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03392363 |
Recruitment Status :
Completed
First Posted : January 5, 2018
Last Update Posted : November 8, 2018
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Condition or disease | Intervention/treatment |
---|---|
Pneumonia Bronchiolitis Asthma Exacerbation Croup Reactive Airway Disease Upper Respiratory Disease Viral Lower Respiratory Tract Infections Lower Respiratory Disease | Device: Recordings of Infants and Children's Cough Sounds |
Study Type : | Observational |
Actual Enrollment : | 1470 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds 2 |
Actual Study Start Date : | January 5, 2018 |
Actual Primary Completion Date : | October 19, 2018 |
Actual Study Completion Date : | October 19, 2018 |
- Device: Recordings of Infants and Children's Cough Sounds
Smartphone recordings of the cough sounds of infants and children presenting to a participating site with signs or symptoms of respiratory disease.
- Diagnosis of pneumonia [ Time Frame: 6 months ]Positive percent agreement and negative percent agreement to diagnose and rule out pneumonia as compared with (1) World Health Organization (WHO) Primary Endpoint Pneumonia (PEP) plus clinical pneumonia, (2) WHO PEP or Other Infiltrate plus clinical pneumonia, (3) Clinical pneumonia alone
- Diagnosis of other childhood respiratory diseases [ Time Frame: 6 months ]Positive percent agreement and negative percent agreement to diagnose and rule out: lower respiratory tract disease (i.e. respiratory condition occurring below the level of the larynx), viral lower respiratory tract infection, bronchiolitis, asthma/reactive airways disease, upper respiratory tract disease, and croup.

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Ages Eligible for Study: | 29 Days to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392363
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Ohio | |
Cleveland Clinic Children's | |
Cleveland, Ohio, United States, 44195 | |
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Peter P Moschovis, MD, MPH | Massachusetts General Hospital |
Responsible Party: | ResApp Health Limited |
ClinicalTrials.gov Identifier: | NCT03392363 |
Other Study ID Numbers: |
17001 |
First Posted: | January 5, 2018 Key Record Dates |
Last Update Posted: | November 8, 2018 |
Last Verified: | November 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Bronchiolitis Respiratory Tract Infections Respiration Disorders Respiratory Tract Diseases Infections |
Lung Diseases Bronchitis Bronchial Diseases Lung Diseases, Obstructive |