Diagnosing Respiratory Disease in Children Using Cough Sounds 2

Pneumonia Clinical Trial

— SMARTCOUGH-C-2  

Official title:

Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392363
• Other study ID #: 17001
• Status: Completed
• Start date: January 5, 2018
• Est. completion date: October 19, 2018

Study information

• Verified date: November 2018
• Source: ResApp Health Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1470
• Est. completion date: October 19, 2018
• Est. primary completion date: October 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma Exacerbation
• Bronchial Hyperreactivity
• Bronchiolitis
• Croup
• Lower Respiratory Disease
• Pneumonia
• Reactive Airway Disease
• Respiration Disorders
• Respiratory Tract Diseases
• Respiratory Tract Infections
• Upper Respiratory Disease
• Viral Lower Respiratory Tract Infections

Intervention

Device:
• Recordings 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic Children's	Cleveland	Ohio
United States	Texas Children's Hospital	Houston	Texas

Sponsors (5)

Lead Sponsor	Collaborator
ResApp Health Limited	Baim Institute for Clinical Research, Massachusetts General Hospital, Texas Children's Hospital, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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