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Diagnosing Respiratory Disease in Children Using Cough Sounds 2 (SMARTCOUGH-C-2)

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
Sponsor:
Collaborators:
Massachusetts General Hospital
The Cleveland Clinic
Texas Children's Hospital
Baim Institute for Clinical Research
Information provided by (Responsible Party):
ResApp Health Limited

Tracking Information
First Submitted Date December 29, 2017
First Posted Date January 5, 2018
Last Update Posted Date November 8, 2018
Actual Study Start Date January 5, 2018
Actual Primary Completion Date October 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 29, 2017)
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03392363 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnosing Respiratory Disease in Children Using Cough Sounds 2
Official Title Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds 2
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, asthma/reactive airways disease, croup, lower respiratory tract disease (LRTD), viral lower respiratory tract infection (vLRTI), and upper respiratory tract disease (URTD).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with signs or symptoms of respiratory disease presenting to participating Emergency Departments, Urgent Care Clinics, Outpatient Clinics or an Inpatient Ward within 24 hours of admission.
Condition
  • Pneumonia
  • Bronchiolitis
  • Asthma Exacerbation
  • Croup
  • Reactive Airway Disease
  • Upper Respiratory Disease
  • Viral Lower Respiratory Tract Infections
  • Lower Respiratory Disease
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 2, 2018)
1470
Original Estimated Enrollment
 (submitted: December 29, 2017)
1667
Actual Study Completion Date October 19, 2018
Actual Primary Completion Date October 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 12 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03392363
Other Study ID Numbers 17001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party ResApp Health Limited
Study Sponsor ResApp Health Limited
Collaborators
  • Massachusetts General Hospital
  • The Cleveland Clinic
  • Texas Children's Hospital
  • Baim Institute for Clinical Research
Investigators
Principal Investigator: Peter P Moschovis, MD, MPH Massachusetts General Hospital
PRS Account ResApp Health Limited
Verification Date November 2018