Safety of a Customized NICU MRI SystemNICU MRINCT01522339

Pilot Study: Safety of a Customized MRI System for Neonatal Imaging

A study testing GE OPTIMA MR430s with HDX/GE Electronics in people with Safety of a Customized NICU MRI System, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to determine the safety of a customized MRI scanner and gather preliminary data on image quality in a group of 10 medically stable infants admitted to the Neonatal Intensive Care Unit (NICU) at Cincinnati Children's Hospital Medical Center (CCHMC). Read more about this study

Who is it for?: Any age
Conditions the study is for: Safety of a Customized NICU MRI System
What is being tested?: GE OPTIMA MR430s with HDX/GE Electronics
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Feb 2012to Apr 2012
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Any infant admitted to the NICU at CCHMC
Medically stable as per the opinion of the attending neonatologist currently on service
Parental consent obtained

Who cannot join

Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants >4.5 kg)
Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology

Trial locations and contacts

1 site in 1 country.

United States1 site

NICU, Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229

Other trials in United States

About this study

Read the detailed description

The current practice of transferring infants from the Neonatal Intensive Care Unit (NICU) to radiology departments and imaging in adult-sized magnetic resonance imaging (MRI) scanners is associated with significant safety and image quality issues. For these reasons, the potential of MRI for diagnosing disease in neonates has yet to be fully realized. The overreaching goal of our research effort is to bring high-performance MRI into the NICU so that neonates can benefit from the same quality of diagnostic imaging as adults. To accomplish this we have converted a commercial small-bore 1.5 Tesla (T) MRI scanner designed for orthopedic use into a neonatal MRI system optimized for whole body imaging of neonates. The purpose of this initial study is to determine the safety of the customized scanner installed in the NICU at Cincinnati Children's Hospital Medical Center (CCHMC) and gather preliminary data on image quality in a group of 10 medically stable infants admitted to the CCHMC NICU.

Conditions: Safety of a Customized NICU MRI System
Being tested: GE OPTIMA MR430s with HDX/GE Electronics
Keywords: NICU, MRI, Neonatal, Safety, Efficacy, Cincinnati

What participants receive

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

GE OPTIMA MR430s with HDX/GE ElectronicsDevice
MRI scan(s) for no longer than 60 minutes

Study groups in NCT01522339
Study group	Role	What they receive
Safety of a Customized NICU MRI System	Experimental	Device: GE OPTIMA MR430s with HDX/GE Electronics Receives: Device: GE OPTIMA MR430s with HDX/GE Electronics

What is being measured

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

Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam
Heart rate and oxygen saturation will be measured every 15+/- 5 minutes. The infants' temperatures will be taken immediately before the MRI and again immediately after the MRI. A physical exam will be performed both immediately before and immediately after the MRI to assess for any physical changes.
Measured: Day 1

Secondary outcomes (1)

MRI Image Quality
The following measures will be individually evaluated and compared to similar images previously acquired on an adult scanner: Overall Study Quality, Motion, Spatial Resolution, Signal to Noise, and Contrast.
Measured: Post MRI Scan for Each Infant

Timeline

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

Feb 2012Apr 2012

First posted31 Jan 2012 (estimated)
Study startFeb 2012
Primary completionApr 2012
Study completionApr 2012

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 Safety of a Customized NICU MRI SystemStudies of the same condition, open and under way.
More trials run by Children's Hospital Medical Center, CincinnatiThe 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
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01522339
Sponsor's protocol ID: 2011-2045
Acronym: NICU MRI
Status last verified: Sep 2014
First submitted: 22 Nov 2011
Last updated: 25 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study: Safety of a Customized MRI System for Neonatal Imaging
ClinicalTrials.gov ID: NCT01522339
Acronym / sponsor ID: NICU MRI / 2011-2045
Conditions: Safety of a Customized NICU MRI System
Keywords: NICU, MRI, Neonatal, Safety, Efficacy, Cincinnati
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Study start: Feb 2012
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 31 Jan 2012 (estimated)
Results: Posted 25 Sep 2014

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Safety of a Customized NICU MRI System	Experimental	Device: GE OPTIMA MR430s with HDX/GE ElectronicsDevice: GE OPTIMA MR430s with HDX/GE Electronics

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Any infant admitted to the NICU at CCHMC
Medically stable as per the opinion of the attending neonatologist currently on service
Parental consent obtained

Key exclusion criteria (2 listed)

Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants >4.5 kg)
Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology

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
GE OPTIMA MR430s with HDX/GE ElectronicsMRI scan(s) for no longer than 60 minutes	Device	Safety of a Customized NICU MRI System

Primary outcome

Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam
Time frame: Day 1
Heart rate and oxygen saturation will be measured every 15+/- 5 minutes. The infants' temperatures will be taken immediately before the MRI and again immediately after the MRI. A physical exam will be performed both immediately before and immediately after the MRI to assess for any physical changes.

1 secondary outcome

MRI Image Quality
Time frame: Post MRI Scan for Each Infant

Results and safety

Results posted to the registry on 25 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pilot Group	15	15

Primary outcome: Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam

Time frame: Day 1. Number. Unit: Adverse Events

Measure	Pilot Group n = 15
Value	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Patients were monitored for approximately 2 hours after the MRI for Adverse Events for skin changes due to the monitor leads.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pilot Group	0 of 15 (0%)	3 of 15 (20%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Charles L Dumoulin, Ph.D. principal investigator

Children's Hospital Medical Center, Cincinnati

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

Questions about this trial

What is this clinical trial studying?

A study testing GE OPTIMA MR430s with HDX/GE Electronics in people with Safety of a Customized NICU MRI System, run by Children's Hospital Medical Center, Cincinnati 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 3 inclusion and 2 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 25 Sep 2014. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2014). 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?

Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam (time frame: Day 1). 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 NCT01522339.

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 25 Sep 2014.