Clinical trial NCT03392363: Diagnosing Respiratory Disease in Children Using Cough Sounds 2
Official title: Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Bronchiolitis
Asthma Exacerbation
Croup
Reactive Airway Disease
Upper Respiratory Disease
Viral Lower Respiratory Tract Infections
Lower Respiratory Disease
Lead sponsor: ResApp Health Limited
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
name: The Cleveland Clinic
name: Baylor College of Medicine
name: Baim Institute for Clinical Research
First posted: 2018-01-05
Enrollment: 1470
Sex: ALL
Minimum age (years): 29
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


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

Primary outcomes:
measure: Diagnosis of pneumonia
timeFrame: 6 months
measure: Diagnosis of other childhood respiratory diseases
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic Children's
state: Ohio
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: Peter P Moschovis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: