- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03476343
Clinical Use of a Neonatal MRI System
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There are significant safety and image quality issues associated with transferring neonates from the Neonatal Intensive Care Unit (NICU) to the main Radiology Department for imaging in an adult-sized magnetic resonance imaging (MRI) scanner. For these reasons, the smallest and/or sickest neonates are typically precluded from receiving an MRI exam. The 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 (NICU MRI). To expand the imaging capabilities of the NICU MRI system, the measurement control electronics and operating system software of the FDA cleared 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). Further we have scanned almost 600 patients under a prior protocol (CCHMC Protocol 2011-2850) without an adverse event.
The present protocol seeks to allow continued performance of clinical MRI exams on the NICU magnet with improved administrative processes and procedures. NICU patients for whom an MRI exam is medically indicated will be recruited for the present study. Images will be obtained using both the FDA cleared OPTIMA NICU MRI platform and the integrated HDX/OPTIMA NICU MRI platform with the additional HDX images augmenting the OPTIMA images and contributing to diagnosis and guidance of subsequent clinical management. The specific MR imaging methods/procedures utilized will be determined by the type of exam to be performed and the medical indication. All of the MR images obtained will be reviewed by a board certified pediatric radiologist as part of clinical care and a clinical report will be generated and included in the infant's medical record.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
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Cincinnati, Ohio, United States, 45229
- NICU, Cincinnati Children's Hospital Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Any infant admitted to CCHMC
- Have a medical condition for which an MRI exam is indicated, as determined by the attending neonatologist
Exclusion Criteria:
- Infants too large to fit in the customized NICU MRI system comfortably (generally infants > 6 kg)
- Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MRI for Neonates
MRI
|
MRI scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events as Observed During and After Scanning.
Time Frame: Day 1
|
Any observed physical changes will be recorded during and after scanning
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Each Infant's Baseline Measurement for Weight Will be Recorded.
Time Frame: Day 1
|
These measures will be used in order to facilitate future design of coils and transport tables for the customized MRI system.
|
Day 1
|
Each Infant's Anatomy Scanned Will be Obtained.
Time Frame: Day 1
|
The anatomy used will be used in order to facilitate understand the need for specific coils for the customized MRI system.
|
Day 1
|
Baseline Measurement for Days Old Will be Recorded.
Time Frame: Day 1
|
These measures will be used in conjunction with the weight at the time of scan to facilitate future design of coils and transport tables for the customized MRI system.
|
Day 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Beth M Kline-Fath, MD, Children's Hospital Medical Center, Cincinnati
Publications and helpful links
General Publications
- Beck S, Wojdyla D, Say L, Betran AP, Merialdi M, Requejo JH, Rubens C, Menon R, Van Look PF. The worldwide incidence of preterm birth: a systematic review of maternal mortality and morbidity. Bull World Health Organ. 2010 Jan;88(1):31-8. doi: 10.2471/BLT.08.062554. Epub 2009 Sep 25.
- Maalouf EF, Duggan PJ, Counsell SJ, Rutherford MA, Cowan F, Azzopardi D, Edwards AD. Comparison of findings on cranial ultrasound and magnetic resonance imaging in preterm infants. Pediatrics. 2001 Apr;107(4):719-27. doi: 10.1542/peds.107.4.719.
- McCormick MC, Behrman RE. The quiet epidemic of premature birth: commentary on a recent Institute of Medicine report. Ambul Pediatr. 2007 Jan-Feb;7(1):8-9. doi: 10.1016/j.ambp.2006.10.002. No abstract available.
- Arthur R. Magnetic resonance imaging in preterm infants. Pediatr Radiol. 2006 Jul;36(7):593-607. doi: 10.1007/s00247-006-0154-x. Epub 2006 May 19.
- Hirsch W, Sorge I, Krohmer S, Weber D, Meier K, Till H. MRI of the lungs in children. Eur J Radiol. 2008 Nov;68(2):278-88. doi: 10.1016/j.ejrad.2008.05.017. Epub 2008 Sep 3.
- Adams EW, Counsell SJ, Hajnal JV, Allsop JM, Herlihy A, Edwards AD. Investigation of lung disease in preterm infants using magnetic resonance imaging. Biol Neonate. 2000 May;77 Suppl 1:17-20. doi: 10.1159/000047053.
- Krishnamurthy R. Neonatal cardiac imaging. Pediatr Radiol. 2010 Apr;40(4):518-27. doi: 10.1007/s00247-010-1549-2.
- Schweigmann G, Gassner I, Maurer K. Imaging the neonatal heart--essentials for the radiologist. Eur J Radiol. 2006 Nov;60(2):159-70. doi: 10.1016/j.ejrad.2006.07.017. Epub 2006 Aug 22.
- Barkovich AJ. MR imaging of the neonatal brain. Neuroimaging Clin N Am. 2006 Feb;16(1):117-35, viii-ix. doi: 10.1016/j.nic.2005.10.003.
- van Wezel-Meijler G, Leijser LM, de Bruine FT, Steggerda SJ, van der Grond J, Walther FJ. Magnetic resonance imaging of the brain in newborn infants: practical aspects. Early Hum Dev. 2009 Feb;85(2):85-92. doi: 10.1016/j.earlhumdev.2008.11.009. Epub 2009 Jan 12.
- Saunders DE, Thompson C, Gunny R, Jones R, Cox T, Chong WK. Magnetic resonance imaging protocols for paediatric neuroradiology. Pediatr Radiol. 2007 Aug;37(8):789-97. doi: 10.1007/s00247-007-0462-9. Epub 2007 May 9.
- Mathur AM, Neil JJ, McKinstry RC, Inder TE. Transport, monitoring, and successful brain MR imaging in unsedated neonates. Pediatr Radiol. 2008 Mar;38(3):260-4. doi: 10.1007/s00247-007-0705-9. Epub 2007 Dec 19.
- Bluml S, Friedlich P, Erberich S, Wood JC, Seri I, Nelson MD Jr. MR imaging of newborns by using an MR-compatible incubator with integrated radiofrequency coils: initial experience. Radiology. 2004 May;231(2):594-601. doi: 10.1148/radiol.2312030166.
- Erberich SG, Friedlich P, Seri I, Nelson MD Jr, Bluml S. Functional MRI in neonates using neonatal head coil and MR compatible incubator. Neuroimage. 2003 Oct;20(2):683-92. doi: 10.1016/S1053-8119(03)00370-7.
- Foran AM, Fitzpatrick JA, Allsop J, Schmitz S, Franklin J, Pamboucas C, O'Regan D, Hajnal JV, Edwards AD. Three-tesla cardiac magnetic resonance imaging for preterm infants. Pediatrics. 2007 Jul;120(1):78-83. doi: 10.1542/peds.2006-3305.
- Groves AM, Chiesa G, Durighel G, Goldring ST, Fitzpatrick JA, Uribe S, Razavi R, Hajnal JV, Edwards AD. Functional cardiac MRI in preterm and term newborns. Arch Dis Child Fetal Neonatal Ed. 2011 Mar;96(2):F86-91. doi: 10.1136/adc.2010.189142. Epub 2010 Oct 21.
- Michael R. Potential of MR-imaging in the paediatric abdomen. Eur J Radiol. 2008 Nov;68(2):235-44. doi: 10.1016/j.ejrad.2008.07.017. Epub 2008 Oct 9.
- Rao P. Neonatal gastrointestinal imaging. Eur J Radiol. 2006 Nov;60(2):171-86. doi: 10.1016/j.ejrad.2006.07.021. Epub 2006 Sep 25.
- Riccabona M. Imaging of the neonatal genito-urinary tract. Eur J Radiol. 2006 Nov;60(2):187-98. doi: 10.1016/j.ejrad.2006.07.022. Epub 2006 Sep 7.
- Darge K, Jaramillo D, Siegel MJ. Whole-body MRI in children: current status and future applications. Eur J Radiol. 2008 Nov;68(2):289-98. doi: 10.1016/j.ejrad.2008.05.018. Epub 2008 Sep 16.
- Olsen OE. Practical body MRI-A paediatric perspective. Eur J Radiol. 2008 Nov;68(2):299-308. doi: 10.1016/j.ejrad.2008.06.034. Epub 2008 Sep 2.
- Seghier ML, Huppi PS. The role of functional magnetic resonance imaging in the study of brain development, injury, and recovery in the newborn. Semin Perinatol. 2010 Feb;34(1):79-86. doi: 10.1053/j.semperi.2009.10.008.
- Simbrunner J, Riccabona M. Imaging of the neonatal CNS. Eur J Radiol. 2006 Nov;60(2):133-51. doi: 10.1016/j.ejrad.2006.07.019. Epub 2006 Sep 14.
- Rutherford M, Srinivasan L, Dyet L, Ward P, Allsop J, Counsell S, Cowan F. Magnetic resonance imaging in perinatal brain injury: clinical presentation, lesions and outcome. Pediatr Radiol. 2006 Jul;36(7):582-92. doi: 10.1007/s00247-006-0164-8. Epub 2006 May 16.
- Bartha AI, Yap KR, Miller SP, Jeremy RJ, Nishimoto M, Vigneron DB, Barkovich AJ, Ferriero DM. The normal neonatal brain: MR imaging, diffusion tensor imaging, and 3D MR spectroscopy in healthy term neonates. AJNR Am J Neuroradiol. 2007 Jun-Jul;28(6):1015-21. doi: 10.3174/ajnr.A0521.
- Glass HC, Bonifacio SL, Sullivan J, Rogers E, Ferriero DM, Goldstein R, Barkovich AJ. Magnetic resonance imaging and ultrasound injury in preterm infants with seizures. J Child Neurol. 2009 Sep;24(9):1105-11. doi: 10.1177/0883073809338328.
- Prager A, Roychowdhury S. Magnetic resonance imaging of the neonatal brain. Indian J Pediatr. 2007 Feb;74(2):173-84. doi: 10.1007/s12098-007-0012-3.
- Roelants-van Rijn AM, Groenendaal F, Beek FJ, Eken P, van Haastert IC, de Vries LS. Parenchymal brain injury in the preterm infant: comparison of cranial ultrasound, MRI and neurodevelopmental outcome. Neuropediatrics. 2001 Apr;32(2):80-9. doi: 10.1055/s-2001-13875.
- Epelman M, Daneman A, Kellenberger CJ, Aziz A, Konen O, Moineddin R, Whyte H, Blaser S. Neonatal encephalopathy: a prospective comparison of head US and MRI. Pediatr Radiol. 2010 Oct;40(10):1640-50. doi: 10.1007/s00247-010-1634-6. Epub 2010 Apr 22.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CIN_NICUclinicalMRI_003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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