N/A
N=15
Pilot Study: Safety of a Customized MRI System for Neonatal Imaging
Safety of a Customized NICU MRI System
Bottom Line
View on ClinicalTrials.gov: NCT01522339 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam — 0 Adverse Events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GE OPTIMA MR430s with HDX/GE Electronics (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam |
— | — |
| SECONDARY MRI Image Quality |
15 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01522339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.