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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01522339
First received: November 22, 2011
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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 Intervention
Safety of a Customized NICU MRI System
Device: GE OPTIMA MR430s with HDX/GE Electronics

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pilot Study: Safety of a Customized MRI System for Neonatal Imaging

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Number of participants with adverse events as measured by vital signs, change in temperature, and physical exam [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    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:
  • MRI Image Quality [ Time Frame: Post MRI Scan for Each Infant ] [ Designated as safety issue: No ]
    The following measures will be individually evaluated on a 3 point scale: Overall Study Quality, Motion, Spatial Resolution, Signal to Noise, and Contrast.


Enrollment: 15
Study Start Date: January 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: GE OPTIMA MR430s with HDX/GE Electronics
    MRI scan(s) for no longer than 60 minutes
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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522339

Locations
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
Principal Investigator: Charles L Dumoulin, Ph.D. Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01522339     History of Changes
Other Study ID Numbers: 2011-2045
Study First Received: November 22, 2011
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
NICU
MRI
Neonatal
Safety
Efficacy
Cincinnati

ClinicalTrials.gov processed this record on August 28, 2014