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

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

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.

Study Overview

• Status: Terminated
• Conditions: Image Evaluation
• Intervention / Treatment: Device: 3.0 T Neonatal MRI Scanner

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 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.

This is a two-phase prospective clinical study evaluating the performance and safety of the investigational MRI device for neonates and infants, including:

• Phase 1 - Initial feasibility assessment and optimization study (Phase 1) which may include hardware and software modifications. These studies are guided by a series of MR scanning procedures defined in sequential Sponsor-provided MR Procedure Documents
• Phase 2 - Controlled image and data collection study based on Phase 1 results, in which optimized scan procedure(s) according to MR Procedure Document(s) will be provided at the start of Phase 2 scanning and a fixed hardware and integrated software configuration will be applied for all subjects.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects will be included that are:

1. Currently admitted for treatment or observation at the investigational site at the time of enrollment;
2. In the weight range less than 5.0 kg (<5.0 kg ) and more than 0.5 kg (>0.5 kg );
3. Viable neonates (birth to 1 month of age) or infants (>1 month to two years of age);
4. Able to safely undergo an MRI scan, as determined by the site's co-investigator neonatologist or medically qualified delegate;
5. Have parent(s), guardian(s), or legally authorized representative(s) willing and able to provide written informed consent for the subject's participation;

6. 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:

   1. Maximum width (shoulder-to-shoulder measurement) less than eighteen (18 cm).
   2. Maximum length (head-to-foot measurement) less than sixty (60) cm. -

Exclusion Criteria:

• Subjects will be excluded that:

  1. 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;
  2. 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;
  3. 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;
  4. 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
  5. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 3.0 T Neonatal Scanner; 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; Eligible subjects will undergo neonatal MRI scanning procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI Scan Time	Duration of MRI scan time for each subject	1 Day
Overall Experience With Neonatal MR Scanner Device Summary	User survey results on a scale from 1 to 5, where 1 = strongly disagree and 5 = strongly agree.	1 day
Overall Image Quality	Scores range from 1-Very Poor image quality to 5-Excellent image quality.	1 day
Subject Change in Temperature	Change in temperature (Celsius) per subject.	1 Day

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: Wellcome Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2015
• Primary Completion (Actual): November 30, 2016
• Study Completion (Actual): November 30, 2016

Study Registration Dates

• First Submitted: August 15, 2014
• First Submitted That Met QC Criteria: September 2, 2014
• First Posted (Estimate): September 4, 2014

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Infant; Neonate
• Other Study ID Numbers: 114-2013-GES-0011