Status:
TERMINATED
Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit
Lead Sponsor:
GE Healthcare
Collaborating Sponsors:
Wellcome Trust
Conditions:
Image Evaluation
Eligibility:
All Genders
Up to 2 years
Phase:
NA
Brief Summary
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations. This MR system has a smaller size and design features that m...
Detailed Description
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations. This MR system has a smaller size and design features that m...
Eligibility Criteria
Inclusion
- Subjects will be included that are:
- Currently admitted for treatment or observation at the investigational site at the time of enrollment;
- In the weight range less than 5.0 kg (\<5.0 kg ) and more than 0.5 kg (\>0.5 kg );
- Viable neonates (birth to 1 month of age) or infants (\>1 month to two years of age);
- Able to safely undergo an MRI scan, as determined by the site's co-investigator neonatologist or medically qualified delegate;
- Have parent(s), guardian(s), or legally authorized representative(s) willing and able to provide written informed consent for the subject's participation;
- Are of appropriate size and shape to fit into the bore of the magnet, inclusive of all monitoring equipment, if any, necessary for the subject's routine clinical care:
- Maximum width (shoulder-to-shoulder measurement) less than eighteen (18 cm).
- Maximum length (head-to-foot measurement) less than sixty (60) cm. -
Exclusion
- Subjects will be excluded that:
- Have parent(s), guardian(s), or legally authorized representative(s) that require that they accompany the subject into the MR environment that have contraindications to the MR environment or would otherwise be put at undue risk or discomfort, as determined by the investigators;
- Require any non-removable medical devices that are not compatible with MR scanning (labeled as MR Unsafe, MR condition for which the scanning conditions are not met, or no MR safety labeling) that may pose hazards in the MR scanning or MR environment, in the opinion of the neonatologist co-investigator or medically qualified delegate;
- Have other contraindications or could otherwise be expected to experience detrimental effects to safety, well-being, or medical care, as determined by the neonatologist co-investigator;
- Require any scheduled standard of care procedures that are expected to be adversely impacted by participation in this study, in the opinion of the principal investigator, neonatologist co-investigator, or medically qualified delegate; and
- Have been previously enrolled AND undergone any study procedures under the current study protocol (i.e. the same subject cannot undergo study procedures, including swaddling and/or MR scanning, more than once).
Key Trial Info
Start Date :
May 7 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02232009
Start Date
May 7 2015
End Date
November 30 2016
Last Update
January 30 2019
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115