Thermal Imaging, Neonatal Pneumonia, TachypneaPhase 1NCT02570828
Thermal Imaging in Neonates: A Feasibility Study in Healthy Babies and Babies With Suspected TTN
A Phase 1 study testing Thermal Imaging in people with Thermal Imaging, Neonatal Pneumonia, Tachypnea, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Thermal Imaging, Neonatal Pneumonia, Tachypnea
- What is being tested?
- Thermal Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- parents do not consent to have baby participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
- Being tested
- Thermal Imaging
- Keywords
- healthy neonate, tachypnea, thermal imaging, pneumonia
- Medical subject headings
- Tachypnea, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal ImagingDevice
FLIR ONE attachment to an iPhone
| Study group | Role | What they receive |
|---|---|---|
| Thermal imaging | Experimental | All subjects in the study will have thermal images of the chest taken using the FLIR ONE attachment to an iPhone. Receives: Device: Thermal Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
asymmetric heat distribution
thermal imaging will be used to capture asymmetric heat distribution across lung fields
Measured: within the first 3 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermal Imaging, Neonatal Pneumonia, TachypneaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia L. Hibberd, Massachusetts General Hospital
- Investigators
- Patricia L Hibberd, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570828
- Sponsor's protocol ID
- 2015P001500
- Status last verified
- Jan 2017
- First submitted
- 6 Oct 2015
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Imaging in Neonates: a Feasibility Study in Healthy Babies and Babies With Suspected Transient Tachypnea of the Newborn (TTN)
- ClinicalTrials.gov ID
- NCT02570828
- Acronym / sponsor ID
- 2015P001500
- Keywords
- healthy neonate, tachypnea, thermal imaging, pneumonia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thermal imaging | Experimental | Device: Thermal ImagingAll subjects in the study will have thermal images of the chest taken using the FLIR ONE attachment to an iPhone. |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- parents do not consent to have baby participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal ImagingFLIR ONE attachment to an iPhone | Device | Thermal imaging |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia L Hibberd, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thermal Imaging in people with Thermal Imaging, Neonatal Pneumonia, Tachypnea, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
asymmetric heat distribution (time frame: within the first 3 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.