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

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ClinicalTrials.gov Identifier: NCT03392363
Recruitment Status : Active, not recruiting
First Posted : January 5, 2018
Last Update Posted : August 3, 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

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).

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
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough Pneumonia


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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

  2. 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:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
ResApp Health Limited
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

Responsible Party: ResApp Health Limited
ClinicalTrials.gov Identifier: NCT03392363     History of Changes
Other Study ID Numbers: 17001
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Pneumonia
Bronchiolitis
Respiratory Tract Infections
Respiration Disorders
Respiratory Tract Diseases
Bronchial Hyperreactivity
Lung Diseases
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Infection