Clinical trial NCT01801865: Clinical Use of a New Neonatal MRI System
Official title: Clinical Use of a New Neonatal MRI System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnetic Resonance Imaging
Keywords: NICU
MRI
Neonatal
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 657
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events as Observed During and After Scanning.
timeFrame: Day 1
Secondary outcomes:
measure: Each Infant's Baseline Measurement for Weight Will be Recorded to Ensure the Infant is Less Than 6 kg.
timeFrame: Day 1
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: NICU, Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Beth M Kline-Fath, MD
role: PRINCIPAL_INVESTIGATOR
References: