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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02973282
Other study ID # 16001
Secondary ID
Status Completed
Phase N/A
First received November 22, 2016
Last updated January 3, 2018
Start date December 2016
Est. completion date December 2017

Study information

Verified date January 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 diagnosis of pneumonia and other respiratory conditions (bronchiolitis, asthma/reactive airway disease, croup, upper or lower respiratory tract infections) in infants and children. Patient's cough sounds will be recorded using a smartphone and analysed using the ResAppDx software. The ResAppDx diagnosis will be compared to radiologic diagnosis and/or clinical diagnosis. The ResAppDx diagnosis will not be provided to the clinician or patient.


Recruitment information / eligibility

Status Completed
Enrollment 1245
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 12 Years
Eligibility Inclusion Criteria:

- Infant or child aged 29 days - 12 years

- Presenting to the study site with signs or symptoms of respiratory disease including cough, wheezing, stridor, chest in-drawing/retractions, difficulty breathing, fast breathing, abnormal lung sounds on exam, cyanosis/hypoxemia.

- 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, continuous positive airway pressure, or bilevel positive airway pressure) or high flow nasal cannula

- Any medical contraindication to voluntary cough, including (only enrolled if coughing spontaneously): severe respiratory distress, history of pneumothorax, eye/chest/abdominal surgery in past 3 months, hemoptysis in the past month, or too medically unstable to participate in study per treating clinician.

- Subject previously enrolled

- Tracheostomy present or tube placed

Study Design


Intervention

Other:
Recording 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 (4)

Lead Sponsor Collaborator
ResApp Health Limited 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 a radiologic diagnosis.
Positive percent agreement and negative percent agreement to diagnose and rule out pneumonia as compared with a clinical diagnosis.
6 months
Secondary Diagnosis of other childhood respiratory diseases Positive percent agreement and negative percent agreement to diagnose and rule out: lower respiratory tract involvement, bronchiolitis, asthma/reactive airway disease, upper respiratory tract infection and/or croup, as compared with a clinical diagnosis. 6 months
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