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

NCT ID: NCT02570828

Last Updated: 2017-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-07-31

Brief Summary

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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

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Conditions

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Thermal Imaging, Neonatal Pneumonia, Tachypnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Thermal imaging

All subjects in the study will have thermal images of the chest taken using the FLIR ONE attachment to an iPhone.

Group Type EXPERIMENTAL

Thermal Imaging

Intervention Type DEVICE

FLIR ONE attachment to an iPhone

Interventions

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Thermal Imaging

FLIR ONE attachment to an iPhone

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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


* 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
Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Patricia L. Hibberd

Chief, Division of Global Health, Department of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia L Hibberd, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2015P001500

Identifier Type: -

Identifier Source: org_study_id

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