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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01522339
Recruitment Status : Completed
First Posted : January 31, 2012
Results First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Safety of a Customized NICU MRI System Device: GE OPTIMA MR430s with HDX/GE Electronics Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pilot Study: Safety of a Customized MRI System for Neonatal Imaging
Study Start Date : February 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Safety of a Customized NICU MRI System
Device: GE OPTIMA MR430s with HDX/GE Electronics
 Device: GE OPTIMA MR430s with HDX/GE Electronics
MRI scan(s) for no longer than 60 minutes


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. MRI Image Quality [ Time Frame: Post MRI Scan for Each Infant ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522339


Locations
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United States, Ohio
NICU, Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Charles L Dumoulin, Ph.D. Children's Hospital Medical Center, Cincinnati
More Information
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01522339    
Other Study ID Numbers: 2011-2045
First Posted: January 31, 2012    Key Record Dates
Results First Posted: September 25, 2014
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by Children's Hospital Medical Center, Cincinnati:
NICU
MRI
Neonatal
 Safety
Efficacy
Cincinnati