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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03392363
Other study ID # 17001
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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