Clinical Use of a New Neonatal MRI System

Magnetic Resonance Imaging Clinical Trial

Official title:

Clinical Use of a New Neonatal MRI System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801865
• Other study ID #: 2011-2850
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: March 2018

Study information

• Verified date: October 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the present study is to make medically indicated state of the art/high end magnetic resonance imaging (MRI) exams available to all infants in the Cincinnati Children's Hospital Medical Center (CCHMC) Neonatal Intensive Care Unit (NICU).

Description:

The current practice of transferring infants from the Neonatal Intensive Care Unit (NICU) to radiology departments and imaging in adult-sized magnetic resonance imaging (MRI) scanners is associated with significant safety and image quality issues. For these reasons, the smallest and/or sickest neonates are typically precluded from receiving an MRI exam. The overreaching goal of our research effort is to bring high-performance MRI into the NICU so that all neonates can benefit from the same quality of diagnostic imaging as adults. To accomplish this, we have converted a commercial small-bore 1.5 Tesla (T) MRI scanner designed for orthopedic use into a neonatal MRI system optimized for whole body imaging of neonates. To expand the imaging capabilities of the NICU MRI system, the measurement control electronics and operating system software of the FDA cleared imaging OPTIMA platform have been augmented with state of the art HDX electronics and software currently used on a conventional commercially available adult sized whole body MRI scanner. The clinical safety of the integrated HDX/OPTIMA NICU MRI system and its ability to produce diagnostic image quality has been shown in 15 pilot patients (CCHMC Protocol 2011-2045). The present protocol builds and expands upon the previous to use the integrated NICU MRI system to perform MRI exams in the neonatal population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 657
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any infant admitted to the NICU at CCHMC
• Have a medical condition for which an MRI exam is indicated, as determined by the attending neonatologist
• Able to maintain body temperature for at least 90 minutes without the aid of an incubator or radiant warmer int he opinion of the attending neonatologist
• Parental/LAR permission obtained

Exclusion Criteria:

• Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants heavier than 6 kg)
• Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology

Related Conditions & MeSH terms

• Magnetic Resonance Imaging

Intervention

Device:
• GE OPTIMA MR430s with HDX/GE Electronics

Locations

Country	Name	City	State
United States	NICU, Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events as Observed During and After Scanning.	Any observed physical changes either related or not related to the MRI was recorded during and after scanning.	Day 1
Secondary	Each Infant's Baseline Measurement for Weight Will be Recorded to Ensure the Infant is Less Than 6 kg.	These measures will be used in order to facilitate future design of coils and transport tables for the customized MRI system.	Day 1