Pilot Study: Safety of a Customized MRI System for Neonatal Imaging
NICU MRI
1 other identifier
interventional
15
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2011
CompletedFirst Posted
Study publicly available on registry
January 31, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
September 25, 2014
CompletedSeptember 25, 2014
September 1, 2014
2 months
November 22, 2011
August 8, 2013
September 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 1
Secondary Outcomes (1)
MRI Image Quality
Post MRI Scan for Each Infant
Study Arms (1)
Safety of a Customized NICU MRI System
EXPERIMENTALDevice: GE OPTIMA MR430s with HDX/GE Electronics
Interventions
MRI scan(s) for no longer than 60 minutes
Eligibility Criteria
You may qualify if:
- Any infant admitted to the NICU at CCHMC
- Medically stable as per the opinion of the attending neonatologist currently on service
- Parental consent obtained
You may not qualify if:
- Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants \>4.5 kg)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NICU, Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Results Point of Contact
- Title
- Jean Tkach
- Organization
- Cincinnati Children's Hospital Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Charles L Dumoulin, Ph.D.
Children's Hospital Medical Center, Cincinnati
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2011
First Posted
January 31, 2012
Study Start
February 1, 2012
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
September 25, 2014
Results First Posted
September 25, 2014
Record last verified: 2014-09