Pneumonia Clinical Trial
— SMARTCOUGH-C-2Official title:
Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds 2
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 |
Verified date | November 2018 |
Source | ResApp Health Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
ResApp Health Limited | Baim Institute for Clinical Research, Massachusetts General Hospital, Texas Children's Hospital, The Cleveland Clinic |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04244474 -
Effect of Vitamin D Supplementation on Improvement of Pneumonic Children
|
Phase 1/Phase 2 | |
Completed |
NCT05815264 -
Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above
|
Phase 1 | |
Recruiting |
NCT04589936 -
Prone Position to Improve Oxygenation in COVID-19 Patients Outside Critical Care
|
N/A | |
Completed |
NCT02905383 -
The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital
|
N/A | |
Terminated |
NCT03944551 -
Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa
|
N/A | |
Completed |
NCT06210737 -
A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months,7 Months-5 Years
|
Phase 4 | |
Terminated |
NCT04660084 -
Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP
|
N/A | |
Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
Withdrawn |
NCT05702788 -
Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)
|
Phase 2 | |
Not yet recruiting |
NCT04171674 -
Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation.
|
N/A | |
Active, not recruiting |
NCT03140163 -
Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]
|
N/A | |
Completed |
NCT02864420 -
Hospitalization at Home: The Acute Care Home Hospital Program for Adults
|
N/A | |
Completed |
NCT02638649 -
Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
|
||
Recruiting |
NCT02515565 -
Physiotherapy in Patients Hospitalized Due to Pneumonia.
|
N/A | |
Completed |
NCT02105298 -
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
|
N/A | |
Completed |
NCT01416519 -
Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation
|
N/A | |
Completed |
NCT01399723 -
Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia
|
Phase 3 | |
Completed |
NCT01446926 -
Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants
|
Phase 1 | |
Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A | |
Completed |
NCT01416506 -
Community-Acquired Pneumonia (CAP) Surveillance
|
N/A |