Diagnosing Respiratory Disease in Children Using Cough Sounds 2

NCT03392363 | Completed

• 1 other identifier: 17001
• Study Type: observational
• Target: 1,470
• Locations: 1 country
• Sites: 3

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).

Conditions

Pneumonia; Bronchiolitis; Asthma Exacerbation; Croup; Reactive Airway Disease; Upper Respiratory Disease; Viral Lower Respiratory Tract Infections; Lower Respiratory Disease

Outcome Measures

Primary Outcomes (2)

• Diagnosis of pneumonia

  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

  6 months

• Diagnosis of other childhood respiratory diseases

  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.

  6 months

Interventions

Recordings of Infants and Children's Cough Sounds DEVICE

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, Outpatient Clinics or an Inpatient Ward within 24 hours of admission.

You may qualify if:

• 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

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, 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

Sponsors & Collaborators

• ResApp Health Limited: lead
• Massachusetts General Hospital: collaborator
• The Cleveland Clinic: collaborator
• Baylor College of Medicine: collaborator
• Baim Institute for Clinical Research: 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; Croup; Pulmonary Disease, Chronic Obstructive; Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; 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: December 29, 2017
• First Posted: January 5, 2018
• Study Start: January 5, 2018
• Primary Completion: October 19, 2018
• Study Completion: October 19, 2018
• Last Updated: November 8, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)