Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit (Firefly Sheffield)

NCT02785588 | Completed Results

• 1 other identifier: 114-2014-GES-0035
• Study Type: interventional
• Target: 54
• 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 (\>1 month to two years), such as clinical neonatal intensive care units (NICUs) and other infant and neonatal care departments.

Conditions

Neonatal Neuroimaging

Keywords

MRI Scanner; NICU

Outcome Measures

Primary Outcomes (4)

• Image Diagnostic Quality for Phase 1

  Number of subject whose images were rated as Evaluable.

  1 Day

• Number of Participants Who Experienced an Adverse Event in Phase 1

  Safety will be assessed based on the number of Adverse Events in Phase 1.

  1 Day

• Image Diagnostic Quality for Phase 2

  Number of subject whose images were rated as Evaluable.

  1 Day

• Number of Participants Who Experienced an Adverse Event in Phase 2

  Safety will be assessed based on the number of Adverse Events in Phase 2.

  1 Day

Secondary Outcomes (7)

• Summary of Image Quality and Assessment for Phase 1

  1 Day

• Summary of Image Quality and Assessments for Phase 2

  1 Day

• Per Subject Workflow and Transport Information

  1 Day

• Overall Experience With the Neonatal MR Scanner Device Summary

  1 Day

• Bi-polar Product Description Scale

  1 Day

Study Arms (1)

3.0 T Neonatal MRI 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 scan procedure

3.0 T Neonatal MRI scanner

Eligibility Criteria

• Age: 1 Minute - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Currently admitted for treatment or observation at the investigational site at the time of enrolment;
• 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 medically qualified personnel;
• 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 based on standard of care measurement methods, in accordance with site policies :
• 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:

• 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 medically qualified personnel;
• Have any ferrous or electrical items or non-removable medical devices that are not compatible with MR scanning (including devices labelled as MR Unsafe, MR conditional for which the scanning conditions are not met, or without MR safety labelling that does not satisfy site MR safety requirements) that may pose hazards in the MR scanning or MR environment, in the opinion of the Principal Investigator or medically qualified personnel in accordance with the site's MR Safety policy;
• Have any contraindications or could otherwise be expected to experience detrimental effects to safety, well-being, or medical care, as determined by the Principal Investigator or medically qualified personnel in accordance with the site's MR Safety policy;
• 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 or medically qualified personnel; 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)

University of Sheffield, Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

Results Point of Contact

• Title: Yvonne Celestial
• Organization: GE Healthcare

MarieYvonne.CELESTIAL@ge.com

+33 130709133

Study Officials

• Paul Griffiths, MD, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

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: May 19, 2016
• First Posted: May 30, 2016
• Study Start: March 22, 2016
• Primary Completion: August 20, 2017
• Study Completion: April 20, 2018
• Last Updated: September 13, 2019
• Results First Posted: September 13, 2019

Record last verified: 2019-08

Locations

GB (1)