Thermal Imaging in Neonates: A Feasibility Study in Healt... | NCT02570828

Studies
Thermal Imaging in Neonates: A Feasibility Study in Healthy Babies and Babies With Suspected TTN

NCT02570828

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Jan 16, 2017Estimated

Enrollment

25Actual

Phase

Phase 1

Conditions

Thermal Imaging, Neonatal Pneumonia, Tachypnea

Interventions

Thermal Imaging

Countries

United States

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

Status Module

Record Verification Date

Jan 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

Oct 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Oct 6, 2015

First Submission Date that Met QC Criteria

Oct 6, 2015

First Posted Date

Oct 7, 2015Estimated

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

Jan 12, 2017

Last Update Posted Date

Jan 16, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patricia L. Hibberd, Chief, Division of Global Health, Department of Pediatrics, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 to evaluate thermal imaging as a technology to monitor the normal clearing of amniotic fluid from healthy newborns and newborns suspected of having a condition called transient tachypnea of the newborn, or TTN. Thermal images are taken using an imaging device that attaches to an iPhone. This device, commercially known as FLIR ONE, creates a non-identifiable image based on the heat pattern of an object. In this case, the object is a child's chest and back. It does not emit any radiation like an x-ray does.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thermal imaging	Experimental	All subjects in the study will have thermal images of the chest taken using the FLIR ONE attachment to an iPhone.	Device: Thermal Imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thermal Imaging	Device	FLIR ONE attachment to an iPhone	Thermal imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
asymmetric heat distribution	thermal imaging will be used to capture asymmetric heat distribution across lung fields	within the first 3 days of life

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria (healthy and suspected TTN babies):

Full term (greater than or equal to 37 weeks gestation)
less than 3 days old
born via normal vaginal delivery

Inclusion Criteria (only for suspected TTN babies):

neonatologist assesses baby as possibly having TTN
chest x-ray done as part of evaluation for TTN
no other significant co-morbid conditions present

Exclusion Criteria:

parents do not consent to have baby participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patricia L Hibberd, MD, PhD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

Condition Browse Module

MeSH Terms

ID	Term
D059246	Tachypnea
D011014	Pneumonia

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided