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

Not Applicable

• Conditions: Infections - Bacterial; Pneumonia - Bacterial
• Interventions: Device: FLIR ONE

• Registration Number: NCT02908399
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-21
• Study Start: 2016-10
• Primary Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thermal Imaging	FLIR ONE	Imaging using a thermal camera

Primary Outcome Measures

Name	Time	Method
diagnosis of bacterial pneumonia	24 hours	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

Name	Time	Method
diagnosis of additional site of infection possibly related to bacterial pneumonia	up to a maximum of 28 days after original chest x-ray to diagnose pneumonia is taken	Thermal imaging will be used to image other potential sites of infection suspected of being related to the bacterial pneumonia if suspected by physician

Trial Locations

Locations (1)

National Institute of Child Health; 🇵🇰 Karachi, Pakistan