Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit

NCT02232009 | Terminated Results

• 1 other identifier: 114-2013-GES-0011
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 may make it more feasible to locate the system in close proximity to care areas for neonates (birth - 1 month) and infants (less than 1 month to two years), such as clinical neonatal intensive care units (NICUs) and other infant and neonatal care departments.

Conditions

Image Evaluation

Keywords

Neonate; Infant

Outcome Measures

Primary Outcomes (2)

• Summary Rates of Adverse Events

  Safety will be assessed based on the number of Adverse Events.

  1 Day

• Image Diagnostic Quality

  Number of subject whose images were rated as Evaluable

  1 Day

Secondary Outcomes (4)

• MRI Scan Time

  1 Day

• Overall Experience With Neonatal MR Scanner Device Summary

  1 day

• Overall Image Quality

  1 day

• Subject Change in Temperature

  1 Day

Study Arms (1)

3.0 T Neonatal Scanner

OTHER

All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.

Device: 3.0 T Neonatal MRI Scanner

Interventions

3.0 T Neonatal MRI Scanner DEVICE

Eligible subjects will undergo neonatal MRI scanning procedures.

3.0 T Neonatal Scanner

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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. -

You may not qualify if:

• 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).

Sponsors & Collaborators

• GE Healthcare: lead
• Wellcome Trust: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Results Point of Contact

• Title: Yvonne Celestial
• Organization: GE Healthcare

MarieYvonne.CELESTIAL@ge.com

+33 130709133

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: September 4, 2014
• Study Start: May 7, 2015
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: January 30, 2019
• Results First Posted: January 30, 2019

Record last verified: 2019-01

Locations

US (1)