Thermal Imaging of the Lung on a Smartphone to Differenti... | NCT02778672

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

NCT02778672

Sponsor

Boston University

Status

Completed

Last Update Posted

Sep 8, 2017Actual

Enrollment

273Actual

Phase

Not provided

Conditions

Pneumonia, Bacterial
Infections, Bacterial

Interventions

Thermal imaging of infant's chest with a mobile phone

Countries

Malawi

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
OPP1140544	Other Grant/Funding Number	Bill and Melinda Gates Foundation

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

May 16, 2016

First Submission Date that Met QC Criteria

May 17, 2016

First Posted Date

May 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2017

Last Update Posted Date

Sep 8, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patricia Hibberd, Chair School of Public Health, Department of Global Health, Boston UniversityPrincipal Investigator

Lead Sponsor

Boston UniversityOTHER

Collaborators

Name	Class
Bill and Melinda Gates Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

273Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infants with potential pneumonia			Other: Thermal imaging of infant's chest with a mobile phone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thermal imaging of infant's chest with a mobile phone	Other		Infants with potential pneumonia

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Months

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patricia L Hibberd, MD, PhD	Boston University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Elizabeth Central Hospital		Blantyre			Malawi

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018410	Pneumonia, Bacterial
D001424	Bacterial Infections

Ancestor Terms

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections
D011014	Pneumonia
D012141	Respiratory Tract Infections

Browse Leaves

Not provided

Browse Branches

Not provided