Thermal Images on Smartphones to Diagnose Bacterial Pneumonia in Children in Pakistan
Primary Purpose
Infections - Bacterial, Pneumonia - Bacterial
Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
FLIR ONE
Sponsored by
About this trial
This is an interventional diagnostic trial for Infections - Bacterial
Eligibility Criteria
Inclusion Criteria:
- 18 months or younger;
- patient at NICH Hospital in Karachi, Pakistan;
- had chest x-ray within last 24 hours to determine diagnosis of bacterial pneumonia;
- consent obtained from one parent
Exclusion Criteria:
- thermal image cannot be done within 24 hours of chest x-ray
Sites / Locations
- National Institute of Child Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thermal Imaging
Arm Description
Imaging using a thermal camera
Outcomes
Primary Outcome Measures
diagnosis of bacterial pneumonia
Pneumonia is defined as the presence of an airspace opacity, lobar consolidation, or interstitial opacities on a chest x-ray. This determination will be made by two independent radiologists blinded to each other's readings, clinical information and thermal images. If they agree that pneumonia is either present or absent, that will be the final diagnosis. If there is disagreement, a third independent, blinded radiologist will break the tie.
Secondary Outcome Measures
diagnosis of additional site of infection possibly related to bacterial pneumonia
Thermal imaging will be used to image other potential sites of infection suspected of being related to the bacterial pneumonia if suspected by physician
Full Information
NCT ID
NCT02908399
First Posted
September 8, 2016
Last Updated
August 28, 2017
Sponsor
Massachusetts General Hospital
Collaborators
United States Agency for International Development (USAID)
1. Study Identification
Unique Protocol Identification Number
NCT02908399
Brief Title
Thermal Images on Smartphones to Diagnose Bacterial Pneumonia in Children in Pakistan
Official Title
Thermal Images on Smartphones to Diagnose Bacterial Pneumonia in Children in Pakistan
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
United States Agency for International Development (USAID)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective study of up to 250 participants, from birth to 18 months, who have already had a chest x-ray while a patient at the National Institute of Health (NICH) in Karachi, Pakistan. Participants will include both males and females as well as all races and ethnicities. Participants will have thermal pictures of their chest taken by trained study staff using a Smartphone and a FLIR ONE attachment. Thermal images will be read by trained radiologists to determine if bacterial pneumonia is present. Results of the thermal image will then be compared to the results of the chest x-ray. If additional images of the chest or other areas of suspected related infection are available, additional thermal images will be taken of the same location within 24 hours of the other image.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections - Bacterial, Pneumonia - Bacterial
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thermal Imaging
Arm Type
Experimental
Arm Description
Imaging using a thermal camera
Intervention Type
Device
Intervention Name(s)
FLIR ONE
Primary Outcome Measure Information:
Title
diagnosis of bacterial pneumonia
Description
Pneumonia is defined as the presence of an airspace opacity, lobar consolidation, or interstitial opacities on a chest x-ray. This determination will be made by two independent radiologists blinded to each other's readings, clinical information and thermal images. If they agree that pneumonia is either present or absent, that will be the final diagnosis. If there is disagreement, a third independent, blinded radiologist will break the tie.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
diagnosis of additional site of infection possibly related to bacterial pneumonia
Description
Thermal imaging will be used to image other potential sites of infection suspected of being related to the bacterial pneumonia if suspected by physician
Time Frame
up to a maximum of 28 days after original chest x-ray to diagnose pneumonia is taken
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 months or younger;
patient at NICH Hospital in Karachi, Pakistan;
had chest x-ray within last 24 hours to determine diagnosis of bacterial pneumonia;
consent obtained from one parent
Exclusion Criteria:
thermal image cannot be done within 24 hours of chest x-ray
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia L Hibberd, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Child Health
City
Karachi
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Thermal Images on Smartphones to Diagnose Bacterial Pneumonia in Children in Pakistan
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