Diagnosing Respiratory Disease in Children Using Cough Sounds

Study Overview
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Brief Summary
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The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software application in diagnosis of pneumonia and other respiratory conditions (bronchiolitis, asthma/reactive airway disease, croup, upper or lower respiratory tract infections) in infants and children. Patient's cough sounds will be recorded using a smartphone and analysed using the ResAppDx software. The ResAppDx diagnosis will be compared to radiologic diagnosis and/or clinical diagnosis. The ResAppDx diagnosis will not be provided to the clinician or patient.

Official Title
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Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds

Conditions
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Pneumonia, Bronchiolitis, Asthma, Croup, Upper Respiratory Tract Infection, Lower Respiratory Tract Infection, Reactive Airway Disease

Intervention / Treatment
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* Other: Recording of Infants and Children's Cough Sounds


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant or child aged 29 days - 12 years Presenting to the study site with signs or symptoms of respiratory disease including cough, wheezing, stridor, chest in-drawing/retractions, difficulty breathing, fast breathing, abnormal lung sounds on exam, cyanosis/hypoxemia. 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, continuous positive airway pressure, or bilevel positive airway pressure) or high flow nasal cannula Any medical contraindication to voluntary cough, including (only enrolled if coughing spontaneously): severe respiratory distress, history of pneumothorax, eye/chest/abdominal surgery in past 3 months, hemoptysis in the past month, or too medically unstable to participate in study per treating clinician. Subject previously enrolled Tracheostomy present or tube placed

Ages Eligible for Study
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Minimum Age: 29 Days
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Recording 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of pneumonia | Positive percent agreement and negative percent agreement to diagnose and rule out pneumonia as compared with a radiologic diagnosis. Positive percent agreement and negative percent agreement to diagnose and rule out pneumonia as compared with a clinical diagnosis. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of other childhood respiratory diseases | Positive percent agreement and negative percent agreement to diagnose and rule out: lower respiratory tract involvement, bronchiolitis, asthma/reactive airway disease, upper respiratory tract infection and/or croup, as compared with a clinical diagnosis. | 6 months |