NCT02570828

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

October 6, 2015

Last Update Submit

January 12, 2017

Conditions

Thermal Imaging, Neonatal Pneumonia, Tachypnea

Keywords

healthy neonate, tachypnea, thermal imaging, pneumonia

Outcome Measures

Primary Outcomes (1)

  • asymmetric heat distribution

    thermal imaging will be used to capture asymmetric heat distribution across lung fields

    within the first 3 days of life

Study Arms (1)

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

Thermal ImagingDEVICE

FLIR ONE attachment to an iPhone

Thermal imaging

Eligibility Criteria

AgeUp to 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • parents do not consent to have baby participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

TachypneaPneumonia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsLung Diseases

Study Officials

  • Patricia L Hibberd, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Global Health, Department of Pediatrics

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 7, 2015

Study Start

October 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 16, 2017

Record last verified: 2017-01

Locations

US(1)