Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ResApp Health Limited
With
Massachusetts General Hospital
The Cleveland Clinic
Baylor College of Medicine
Baim Institute for Clinical Research
Age
0–12
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
