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

January 12, 2017 updated by: Patricia L. Hibberd, Massachusetts General Hospital

Thermal Imaging in Neonates: a Feasibility Study in Healthy Babies and Babies With Suspected Transient Tachypnea of the Newborn (TTN)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thermal imaging
All subjects in the study will have thermal images of the chest taken using the FLIR ONE attachment to an iPhone.
Device: Thermal Imaging
FLIR ONE attachment to an iPhone

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Patricia L Hibberd, MD, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Estimate)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015P001500

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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