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

NCT02908399 | Unknown

• 1 other identifier: 2016P000898
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections - Bacterial; Pneumonia - Bacterial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Thermal Imaging

EXPERIMENTAL

Imaging using a thermal camera

Device: FLIR ONE

Interventions

FLIR ONE DEVICE

Thermal Imaging

Eligibility Criteria

• Age: Up to 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• thermal image cannot be done within 24 hours of chest x-ray

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

National Institute of Child Health

Karachi, Pakistan

Location

MeSH Terms

Conditions

Bacterial Infections; Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Patricia L Hibberd, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Global Health, Department of Pediatrics

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 21, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

PA (1)