Thermal Images on Smartphones to Diagnose Bacterial Pneumonia in Children in Pakistan

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.

Study Overview

• Status: Unknown
• Conditions: Infections - Bacterial; Pneumonia - Bacterial
• Intervention / Treatment: Device: FLIR ONE

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan
    • National Institute of Child Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thermal Imaging; Imaging using a thermal camera	Device: FLIR ONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to a maximum of 28 days after original chest x-ray to diagnose pneumonia is taken

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: United States Agency for International Development (USAID)
• Investigators: Principal Investigator: Patricia L Hibberd, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 16, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Pneumonia, Bacterial
• Other Study ID Numbers: 2016P000898

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED