Completed

NCT Number: NCT01522339

Pilot Study: Safety of a Customized MRI System for Neonatal Imaging

The purpose of this study is to determine the safety of a customized MRI scanner and gather preliminary data on image quality in a group of 10 medically stable infants admitted to the Neonatal Intensive Care Unit (NICU) at Cincinnati Children's Hospital Medical Center (CCHMC).

Completed

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Key information

Conditions

Safety of a Customized NICU MRI System

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NICU, Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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 potential of MRI for diagnosing disease in neonates has yet to be fully realized. The overreaching goal of our research effort is to bring high-performance MRI into the NICU so that 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. The purpose of this initial study is to determine the safety of the customized scanner installed in the NICU at Cincinnati Children's Hospital Medical Center (CCHMC) and gather preliminary data on image quality in a group of 10 medically stable infants admitted to the CCHMC NICU.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Any infant admitted to the NICU at CCHMC
Medically stable as per the opinion of the attending neonatologist currently on service
Parental consent obtained

Exclusion criteria

Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants >4.5 kg)
Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology

Treatment and study plan

GE OPTIMA MR430s with HDx/GE Electronics

Device

MRI scan(s) for no longer than 60 minutes

Primary outcomes

Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam

Time frame: Day 1

Heart rate and oxygen saturation will be measured every 15+/- 5 minutes. The infants' temperatures will be taken immediately before the MRI and again immediately after the MRI. A physical exam will be performed both immediately before and immediately after the MRI to assess for any physical changes.

Secondary outcomes

MRI Image Quality

Time frame: Post MRI Scan for Each Infant

The following measures will be individually evaluated and compared to similar images previously acquired on an adult scanner: Overall Study Quality, Motion, Spatial Resolution, Signal to Noise, and Contrast.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Acronym: NICU MRI

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Jan 31, 2012
Registry last updated: Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.