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

Thermal Imaging, Neonatal Pneumonia, Tachypnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570828
• Other study ID #: 2015P001500
• Status: Completed
• Phase: Phase 1
• First received: October 6, 2015
• Last updated: January 12, 2017
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: January 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Tachypnea
• Thermal Imaging, Neonatal Pneumonia, Tachypnea
• Transient Tachypnea of the Newborn

Intervention

Device:
• Thermal Imaging
FLIR ONE attachment to an iPhone

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	asymmetric heat distribution	thermal imaging will be used to capture asymmetric heat distribution across lung fields	within the first 3 days of life