Neonatal NeuroimagingNCT02785588

Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit (Firefly Sheffield)

A study testing 3.0 T Neonatal MRI scanner in people with Neonatal Neuroimaging, run by GE Healthcare at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations. This MR system has a smaller size and design features that may make it more feasible to locate the system in close proximity to care areas for neonates (birth - 1 month) and… Read more about this study

Who is it for?: Ages 1 minute to 2 yearsHealthy volunteers can take part
Conditions the study is for: Neonatal Neuroimaging
What is being tested?: 3.0 T Neonatal MRI scanner
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteUnited Kingdom
Study dates: 22 Mar 2016to 20 Apr 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 minute to 2 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Currently admitted for treatment or observation at the investigational site at the time of enrolment;
weight range less than 5.0 kg (<5.0 kg ) and more than 0.5 kg (>0.5 kg );
Viable neonates (birth to 1 month of age) or infants (>1 month to two years of age);
Able to safely undergo an MRI scan, as determined by medically qualified personnel;
Have parent(s), guardian(s), or legally authorized representative(s) willing and able to provide written informed consent for the subject's participation;
Are of appropriate size and shape to fit into the bore of the magnet, inclusive of all monitoring equipment, if any, necessary for the subject's routine clinical care based on standard of care measurement methods, in accordance with site policies :
Maximum width (shoulder-to-shoulder measurement) less than eighteen (18 cm).
Maximum length (head-to-foot measurement) less than sixty (60) cm.

Who cannot join

Have parent(s), guardian(s), or legally authorized representative(s) that require that they accompany the subject into the MR environment that have contraindications to the MR environment or would otherwise be put at undue risk or discomfort, as determined by medically qualified personnel;
Have any ferrous or electrical items or non-removable medical devices that are not compatible with MR scanning (including devices labelled as MR Unsafe, MR conditional for which the scanning conditions are not met, or without MR safety labelling that does not satisfy site MR safety requirements) that may pose hazards in the MR scanning or MR environment, in the opinion of the Principal Investigator or medically qualified personnel in accordance with the site's MR Safety policy;
Have any contraindications or could otherwise be expected to experience detrimental effects to safety, well-being, or medical care, as determined by the Principal Investigator or medically qualified personnel in accordance with the site's MR Safety policy;
Require any scheduled standard of care procedures that are expected to be adversely impacted by participation in this study, in the opinion of the principal investigator or medically qualified personnel; and
Have been previously enrolled AND undergone any study procedures under the current study protocol (i.e. the same subject cannot undergo study procedures, including swaddling and/or MR scanning, more than once).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

University of Sheffield, Royal Hallamshire Hospital
Sheffield, S10 2JF

Other trials in United Kingdom

About this study

Official title: Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit

Read the detailed description

This is a two-phase prospective clinical study evaluating the performance and safety of the investigational MRI device for neonates and infants, including:

Phase 1 - Initial feasibility assessment and optimization study (Phase 1) which may include hardware and software modifications. These studies are guided by a series of MR scanning procedures defined in sequential Sponsor-provided MR Procedure Documents
Phase 2 - Controlled image and data collection study based on Phase 1 results, in which optimized scan procedure(s) according to MR Procedure Document(s) will be provided at the start of Phase 2 scanning and a fixed hardware and integrated software configuration will be applied for all subjects.

Investigator feedback on scanning conducted under each MR Procedure Document will be documented. Because the device is intended for use in viable neonate and infant populations, clinical data are required that cannot be conducted in any other populations or simulated on non-human models. Clinical images and associated data as well as assessments of image quality, workflow, and usability will be collected.

Images, associated image data, and subject data collected in both phases of this study may be used for future engineering development and activities that support MR product development, including Sponsor-authorized scientific and marketing activities. Summary evaluation of safety and performance from Phase 1 and Phase 2 may be used in support of regulatory submission, including filings for European CE mark.

Conditions: Neonatal Neuroimaging
Being tested: 3.0 T Neonatal MRI scanner
Keywords: MRI Scanner, NICU

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3.0 T Neonatal MRI scannerDevice
eligible subjects will undergo neonatal MRI scan procedure

Study groups in NCT02785588
Study group	Role	What they receive
3.0 T Neonatal MRI scanner	Other	All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. Receives: Device: 3.0 T Neonatal MRI scanner

What is being measured

The primary outcome is the main question the study is designed to answer.

Image Diagnostic Quality for Phase 1
Number of subject whose images were rated as Evaluable.
Measured: 1 Day
Number of Participants Who Experienced an Adverse Event in Phase 1
Safety will be assessed based on the number of Adverse Events in Phase 1.
Measured: 1 Day
Image Diagnostic Quality for Phase 2
Number of subject whose images were rated as Evaluable.
Measured: 1 Day
Number of Participants Who Experienced an Adverse Event in Phase 2
Safety will be assessed based on the number of Adverse Events in Phase 2.
Measured: 1 Day

Secondary outcomes (7)

Summary of Image Quality and Assessment for Phase 1
Scores range from 1-Very Poor image quality to 5-Excellent image quality.
Measured: 1 Day
Summary of Image Quality and Assessments for Phase 2
Scores range from 1-Very Poor image quality to 5-Excellent image quality.
Measured: 1 Day
Per Subject Workflow and Transport Information
Summary of means and standard deviations.
Measured: 1 Day
Overall Experience With the Neonatal MR Scanner Device Summary
User survey results on a scale from 1 to 5, where 1 = strongly disagree and 5 = strongly agree.
Question 1. I think that I would like to use this system frequently Question 2. I found the system unnecessarily complex Question 3. I thought the system was easy to use Question 4. I think that I would need support from a technician to be able to use this system Question 5. I found the various functions in this system were well integrated Question 6. I thought there was too much inconsistency in this system Question 7. I think that most people would learn to use this system very quickly Question 8. I found the system very cumbersome to use Question 9. I felt very confident using the system Question 10. I needed to learn a lot of things before I could get going with this system Question 11. I feel confident this system will meet my patient's needs Question 12. How likely is it that you would recommend this system to other professionals in your field?
Measured: 1 Day
Bi-polar Product Description Scale
A measure of bi-polar items (opposite items), rated on a scale from 1 to 7. Closer to 1 indicates a measure closer to the first item and closer to 7 indicates a measure closer to the second item.
Measured: 1 Day
Technical Issues and Malfunctions
Number and type of technical issues and device malfunctions
Measured: 1 Day
Subject Change in Temperature
Measured: 1 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 201620 Apr 2018

First posted30 May 2016 (estimated)
Study start22 Mar 2016
Primary completion20 Aug 2017
Study completion20 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Neonatal NeuroimagingStudies of the same condition, open and under way.
More trials run by GE HealthcareThe 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 N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02785588
Sponsor's protocol ID: 114-2014-GES-0035
Status last verified: Aug 2019
First submitted: 19 May 2016
Last updated: 13 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Neurocognitive Function and Neuroimaging Features in Patients With Glycogen Storage Diseases
Glycogen Storage Disease
Active, not recruiting
Serial Brain MRI in Hospitalized Preterm Infants
Preterm Birth Complication
RecruitingObservational study
Neuroradiological Features of Noonan Syndrome and Genotype-Phenotype Correlations
Noonan Syndrome
Not yet recruitingObservational study
MEMRI: Memory Emergence Using MRI
Not Applicable - Healthy Participants, Focus is the Memory System
RecruitingObservational study
Baby Brain Recovery Study
Perinatal Stroke

All Neonatal Neuroimaging trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit
ClinicalTrials.gov ID: NCT02785588
Acronym / sponsor ID: 114-2014-GES-0035
Conditions: Neonatal Neuroimaging
Keywords: MRI Scanner, NICU
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Collaborators: Wellcome Trust
Study start: 22 Mar 2016 (actual)
Primary completion: 20 Aug 2017 (actual)
Study completion: 20 Apr 2018 (actual)
First posted: 30 May 2016 (estimated)
Results: Posted 13 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a two-phase prospective clinical study evaluating the performance and safety of the investigational MRI device for neonates and infants, including:

Phase 1 - Initial feasibility assessment and optimization study (Phase 1) which may include hardware and software modifications. These studies are guided by a series of MR scanning procedures defined in sequential Sponsor-provided MR Procedure Documents
Phase 2 - Controlled image and data collection study based on Phase 1 results, in which optimized scan procedure(s) according to MR Procedure Document(s) will be provided at the start of Phase 2 scanning and a fixed hardware and integrated software configuration will be applied for all subjects.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
3.0 T Neonatal MRI scanner	Other	Device: 3.0 T Neonatal MRI scannerAll subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.

Who may qualify

Ages: 1 minute to 2 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

Currently admitted for treatment or observation at the investigational site at the time of enrolment;
weight range less than 5.0 kg (<5.0 kg ) and more than 0.5 kg (>0.5 kg );
Viable neonates (birth to 1 month of age) or infants (>1 month to two years of age);
Able to safely undergo an MRI scan, as determined by medically qualified personnel;
Have parent(s), guardian(s), or legally authorized representative(s) willing and able to provide written informed consent for the subject's participation;

Key exclusion criteria (5 listed)

Have parent(s), guardian(s), or legally authorized representative(s) that require that they accompany the subject into the MR environment that have contraindications to the MR environment or would otherwise be put at undue risk or discomfort, as determined by medically qualified personnel;
Have any ferrous or electrical items or non-removable medical devices that are not compatible with MR scanning (including devices labelled as MR Unsafe, MR conditional for which the scanning conditions are not met, or without MR safety labelling that does not satisfy site MR safety requirements) that may pose hazards in the MR scanning or MR environment, in the opinion of the Principal Investigator or medically qualified personnel in accordance with the site's MR Safety policy;
Have any contraindications or could otherwise be expected to experience detrimental effects to safety, well-being, or medical care, as determined by the Principal Investigator or medically qualified personnel in accordance with the site's MR Safety policy;
Require any scheduled standard of care procedures that are expected to be adversely impacted by participation in this study, in the opinion of the principal investigator or medically qualified personnel; and
Have been previously enrolled AND undergone any study procedures under the current study protocol (i.e. the same subject cannot undergo study procedures, including swaddling and/or MR scanning, more than once).

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
3.0 T Neonatal MRI scannereligible subjects will undergo neonatal MRI scan procedure	Device	3.0 T Neonatal MRI scanner

Primary outcome

Image Diagnostic Quality for Phase 1
Time frame: 1 Day
Number of subject whose images were rated as Evaluable.
Number of Participants Who Experienced an Adverse Event in Phase 1
Time frame: 1 Day
Safety will be assessed based on the number of Adverse Events in Phase 1.
Image Diagnostic Quality for Phase 2
Time frame: 1 Day
Number of subject whose images were rated as Evaluable.
Number of Participants Who Experienced an Adverse Event in Phase 2
Time frame: 1 Day
Safety will be assessed based on the number of Adverse Events in Phase 2.

7 secondary outcomes

Summary of Image Quality and Assessment for Phase 1
Time frame: 1 Day
Summary of Image Quality and Assessments for Phase 2
Time frame: 1 Day
Per Subject Workflow and Transport Information
Time frame: 1 Day
Overall Experience With the Neonatal MR Scanner Device Summary
Time frame: 1 Day
Bi-polar Product Description Scale
Time frame: 1 Day
Technical Issues and Malfunctions
Time frame: 1 Day
Subject Change in Temperature
Time frame: 1 Day

Results and safety

Results posted to the registry on 13 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3.0 T Neonatal MRI Scanner	49	47

Primary outcome: Image Diagnostic Quality for Phase 1

Time frame: 1 Day. Count of participants. Unit: Participants

Measure	3.0 T Neonatal MRI Scanner n = 47
Value	24

Primary outcome: Number of Participants Who Experienced an Adverse Event in Phase 1

Time frame: 1 Day. Count of participants. Unit: Participants

Measure	3.0 T Neonatal MRI Scanner n = 47
Value	1

Primary outcome: Image Diagnostic Quality for Phase 2

Time frame: 1 Day. Count of participants. Unit: Participants

Measure	3.0 T Neonatal MRI Scanner n = 5
Value	5

Primary outcome: Number of Participants Who Experienced an Adverse Event in Phase 2

Time frame: 1 Day. Count of participants. Unit: Participants

Measure	3.0 T Neonatal MRI Scanner n = 5
Value	0

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3.0 T Neonatal MRI Scanner	0 of 54 (0%)	1 of 54 (1.9%)	0 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Neonatal Neuroimaging

RecruitingObservational study
Neurocognitive Function and Neuroimaging Features in Patients With Glycogen Storage Diseases
Glycogen Storage Disease
Active, not recruiting
Serial Brain MRI in Hospitalized Preterm Infants
Preterm Birth Complication
RecruitingObservational study
Neuroradiological Features of Noonan Syndrome and Genotype-Phenotype Correlations
Noonan Syndrome
Not yet recruitingObservational study
MEMRI: Memory Emergence Using MRI
Not Applicable - Healthy Participants, Focus is the Memory System
RecruitingObservational study
Baby Brain Recovery Study
Perinatal Stroke

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.

Paul Griffiths, MD, PhD principal investigator

University of Sheffield

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 3.0 T Neonatal MRI scanner in people with Neonatal Neuroimaging, run by GE Healthcare at 1 site in United Kingdom.

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 8 inclusion and 5 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 13 Sep 2019. 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 Kingdom. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Image Diagnostic Quality for Phase 1 (time frame: 1 Day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02785588.

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 13 Sep 2019.