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OpenTrials
Completed

NCT Number: NCT02570828

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

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Key information

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermal Imaging

Device

FLIR ONE attachment to an iPhone

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 7, 2015
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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