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

ResApp Health

Status: Completed

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

Treatments: Other: Recording of Infants and Children's Cough Sounds

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02973282

16001

Details and patient eligibility

About

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.

Enrollment: 1,245 patients

Sex: All

Ages: 29 days to 12 years old

Volunteers: No Healthy Volunteers

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