Magnetic Resonance ImagingNCT01801865
Clinical Use of a New Neonatal MRI System
A study testing GE OPTIMA MR430s with HDX/GE Electronics in people with Magnetic Resonance Imaging, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of the present study is to make medically indicated state of the art/high end magnetic resonance imaging (MRI) exams available to all infants in the Cincinnati Children's Hospital Medical Center (CCHMC) Neonatal Intensive Care Unit (NICU). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Magnetic Resonance Imaging
- 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
- 657 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Mar 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 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
- Have a medical condition for which an MRI exam is indicated, as determined by the attending neonatologist
- Able to maintain body temperature for at least 90 minutes without the aid of an incubator or radiant warmer int he opinion of the attending neonatologist
- Parental/LAR permission obtained
Who cannot join
- Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants heavier than 6 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
About this study
The purpose of the present study is to make medically indicated state of the art/high end magnetic resonance imaging (MRI) exams available to all infants in the Cincinnati Children's Hospital Medical Center (CCHMC) Neonatal Intensive Care Unit (NICU).
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 smallest and/or sickest neonates are typically precluded from receiving an MRI exam. The overreaching goal of our research effort is to bring high-performance MRI into the NICU so that all 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. To expand the imaging capabilities of the NICU MRI system, the measurement control electronics and operating system software of the FDA cleared imaging OPTIMA platform have been augmented with state of the art HDX electronics and software currently used on a conventional commercially available adult sized whole body MRI scanner. The clinical safety of the integrated HDX/OPTIMA NICU MRI system and its ability to produce diagnostic image quality has been shown in 15 pilot patients (CCHMC Protocol 2011-2045). The present protocol builds and expands upon the previous to use the integrated NICU MRI system to perform MRI exams in the neonatal population.
- Conditions
- Magnetic Resonance Imaging
- Being tested
- GE OPTIMA MR430s with HDX/GE Electronics
- Keywords
- NICU, MRI, Neonatal
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
Also called GE OPTIMA 1.5T MRI
| Study group | Role | What they receive |
|---|---|---|
| MRI for Neonates | Experimental | All participants will receive an MRI in the NICU scanner in the GE OPTIMA 1.5T MRI at CCHMC. 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 Observed During and After Scanning.
Any observed physical changes either related or not related to the MRI was recorded during and after scanning.
Measured: Day 1
Secondary outcomes (1)
Each Infant's Baseline Measurement for Weight Will be Recorded to Ensure the Infant is Less Than 6 kg.
These measures will be used in order to facilitate future design of coils and transport tables for the customized MRI system.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startApr 2012
- Primary completionDec 2017
- Study completionMar 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 Magnetic Resonance ImagingStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 657 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beth M Kline-Fath, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801865
- Sponsor's protocol ID
- 2011-2850
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2012
- Last updated
- 23 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Use of a New Neonatal MRI System
- ClinicalTrials.gov ID
- NCT01801865
- Acronym / sponsor ID
- 2011-2850
- Conditions
- Magnetic Resonance Imaging
- Keywords
- NICU, MRI, Neonatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 657 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Posted 27 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study is to make medically indicated state of the art/high end magnetic resonance imaging (MRI) exams available to all infants in the Cincinnati Children's Hospital Medical Center (CCHMC) Neonatal Intensive Care Unit (NICU).
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 smallest and/or sickest neonates are typically precluded from receiving an MRI exam. The overreaching goal of our research effort is to bring high-performance MRI into the NICU so that all 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. To expand the imaging capabilities of the NICU MRI system, the measurement control electronics and operating system software of the FDA cleared imaging OPTIMA platform have been augmented with state of the art HDX electronics and software currently used on a conventional commercially available adult sized whole body MRI scanner. The clinical safety of the integrated HDX/OPTIMA NICU MRI system and its ability to produce diagnostic image quality has been shown in 15 pilot patients (CCHMC Protocol 2011-2045). The present protocol builds and expands upon the previous to use the integrated NICU MRI system to perform MRI exams in the neonatal population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI for Neonates | Experimental | Device: GE OPTIMA MR430s with HDX/GE ElectronicsAll participants will receive an MRI in the NICU scanner in the GE OPTIMA 1.5T MRI at CCHMC. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Any infant admitted to the NICU at CCHMC
- Have a medical condition for which an MRI exam is indicated, as determined by the attending neonatologist
- Able to maintain body temperature for at least 90 minutes without the aid of an incubator or radiant warmer int he opinion of the attending neonatologist
- Parental/LAR permission obtained
Key exclusion criteria (2 listed)
- Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants heavier than 6 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 ElectronicsAlso: GE OPTIMA 1.5T MRI | Device | MRI for Neonates |
Primary outcome
Number of Participants With Adverse Events as Observed During and After Scanning.
Time frame: Day 1
Any observed physical changes either related or not related to the MRI was recorded during and after scanning.
1 secondary outcome
Each Infant's Baseline Measurement for Weight Will be Recorded to Ensure the Infant is Less Than 6 kg.
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Beth M Kline-Fath, MD 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 Magnetic Resonance Imaging, 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 4 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 23 Oct 2026. 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 27 Oct 2020). 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 Observed During and After Scanning. (time frame: Day 1). 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 23 Oct 2026.