Diagnosing Respiratory Disease in Children Using Cough Sounds

NCT02973282 | Completed DMC

• 1 other identifier: 16001
• Study Type: observational
• Target: 1,245
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diagnosis of other childhood respiratory diseases

  6 months

Interventions

Recording of Infants and Children's Cough Sounds OTHER

Smartphone recordings of the cough sounds of infants and children presenting to a participating site with signs or symptoms of respiratory disease

Eligibility Criteria

• Age: 29 Days - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with signs or symptoms of respiratory disease presenting to participating Emergency Departments, Urgent Care Clinics, Primary Care Clinics

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResApp Health Limited: lead
• Massachusetts General Hospital: collaborator
• The Cleveland Clinic: collaborator
• Baylor College of Medicine: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Cleveland Clinic Children's

Cleveland, Ohio, 44195, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pneumonia; Bronchiolitis; Asthma; Croup; Respiratory Tract Infections; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Infections; Lung Diseases; Respiratory Tract Diseases; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Laryngitis; Laryngeal Diseases; Otorhinolaryngologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter P Moschovis, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 25, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)