Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia

This is a study of up to 275 participants from birth to 12 months who are having a chest x-ray while a patient at the Queen Elizabeth Central Hospital in Blantyre, Malawi. 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 study staff to determine if bacterial pneumonia is present. Results of the thermal images will then be compared to the results of the chest X-ray. If additional images of the chest are available, additional thermal images will be taken of the same location within 24 hours of the other image.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Bacterial; Infections, Bacterial
• Intervention / Treatment: Other: Thermal imaging of infant's chest with a mobile phone

• Study Type: Observational
• Enrollment (Actual): 273

Contacts and Locations

Study Locations

• Malawi
  • Blantyre, Malawi
    • Queen Elizabeth Central Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

275 Infants at Queen Elizabeth Central Hospital in Blantyre, Malawi having a chest x-ray done to rule out pneumonia

Description

Inclusion Criteria:

• patient at Queen Elizabeth Central Hospital in Blantyre, Malawi
• having chest x-ray done to rule out pneumonia
• thermal image can be taken within 24 hours of chest x-ray
• parent/guardian provides written informed consent

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infants with potential pneumonia	Other: Thermal imaging of infant's chest with a mobile phone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of concordance between thermal image and the concurrent chest x-ray regarding the diagnosis of bacterial pneumonia	Within 24 hours of the chest x-ray

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Bill and Melinda Gates Foundation
• Investigators: Principal Investigator: Patricia L Hibberd, MD, PhD, Boston University

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 5, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: children; thermal imaging; bacterial pneumonia; diagnosing pneumonia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections and Mycoses; Pneumonia; Pneumonia, Bacterial; Bacterial Infections
• Other Study ID Numbers: H-35690; OPP1140544 (Other Grant/Funding Number: Bill and Melinda Gates Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No