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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pediatric Radio Frequency Coils Generic

NCT01633866

Duchenne Muscular Dystrophy Musculoskeletal Abnormalities

ACTIVE_NOT_RECRUITING

Use of Specially Designed Pediatric MR Coils on Clinical Scanners

NCT01795989

Healthy Volunteers Musculoskeletal Complication

COMPLETED

Magnetic Resonance Elastography in Infants

NCT02201472

Liver Disease

TERMINATED NA

129Xe MRI in Pediatric Population With BPD

NCT04035629

Bronchopulmonary Dysplasia

NOT_YET_RECRUITING PHASE1

Use of Hyperpolarized Xenon Gas for Lung Imaging in Children and Adults

NCT02272049

Respiratory Disorders

RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Safety of a Customized NICU MRI System

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Safety of a Customized NICU MRI System

Device: GE OPTIMA MR430s with HDX/GE Electronics

Group Type EXPERIMENTAL

GE OPTIMA MR430s with HDX/GE Electronics

Intervention Type DEVICE

MRI scan(s) for no longer than 60 minutes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GE OPTIMA MR430s with HDX/GE Electronics

MRI scan(s) for no longer than 60 minutes

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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