INTRODUCTION: MRI and MR spectroscopy (MRS) provide early biomarkers of brain injury and treatment response in neonates with hypoxic-ischaemic encephalopathy). Still, there are challenges to incorporating neuroimaging biomarkers into multisite randomised controlled trials. In this paper, we provide the rationale for incorporating MRI and MRS biomarkers into the multisite, phase III high-dose erythropoietin for asphyxia and encephalopathy (HEAL) Trial, the MRI/S protocol and describe the strategies used for harmonisation across multiple MRI platforms. METHODS AND ANALYSIS: Neonates with moderate or severe encephalopathy enrolled in the multisite HEAL trial undergo MRI and MRS between 96 and 144 hours of age using standardised neuroimaging protocols. MRI and MRS data are processed centrally and used to determine a brain injury score and quantitative measures of lactate and n-acetylaspartate. Harmonisation is achieved through standardisation-thereby reducing intrasite and intersite variance, real-time quality assurance monitoring and phantom scans. ETHICS AND DISSEMINATION: IRB approval was obtained at each participating site and written consent obtained from parents prior to participation in HEAL. Additional oversight is provided by an National Institutes of Health-appointed data safety monitoring board and medical monitor. TRIAL REGISTRATION NUMBER: NCT02811263; Pre-result.
Erythropoietin , Hypoxia-Ischemia, Brain , Asphyxia , Biomarkers , Clinical Trial Protocols as Topic , Humans , Hypoxia-Ischemia, Brain/diagnostic imaging , Hypoxia-Ischemia, Brain/drug therapy , Infant, Newborn , Multicenter Studies as Topic , Neuroimaging
Magnetic resonance imaging of the brain was performed in 26 preterm infants with necrotizing enterocolitis (NEC) or spontaneous intestinal perforation at term equivalent age. Infants with surgical NEC or spontaneous intestinal perforation had significantly more brain injury on magnetic resonance imaging compared with infants with medical NEC, even after adjustment for confounders.
Brain Diseases/diagnosis , Brain/pathology , Enterocolitis, Necrotizing/diagnosis , Infant, Premature, Diseases/diagnosis , Infant, Premature , Intestinal Perforation/diagnosis , Magnetic Resonance Imaging/methods , Brain Diseases/etiology , Enterocolitis, Necrotizing/complications , Enterocolitis, Necrotizing/surgery , Female , Humans , Infant , Infant, Newborn , Infant, Very Low Birth Weight , Intestinal Perforation/complications , Rupture, Spontaneous
Magnetic resonance (MR) imaging is an excellent tool for the evaluation of peripheral nerves in children not only because of its excellent soft tissue contrast resolution but also because it is noninvasive and does not use ionizing radiation. In nonconclusive cases, MR neurography can be complementary to physical examination and electromyography in identifying a specific affected nerve and the site of the lesion. This article reviews the MR imaging technique used in the evaluation of peripheral nerves (ie, MR neurography), its major indications, and the common pathologic conditions encountered in the pediatric population.
Magnetic Resonance Imaging , Neuroimaging/methods , Peripheral Nervous System Diseases/diagnosis , Child , Humans , Magnetic Resonance Imaging/methods , Neurofibroma/diagnosis , Peripheral Nerve Injuries/diagnosis , Peripheral Nervous System Neoplasms/diagnosis
BACKGROUND: Catheter rupture during CT angiography has prompted policies prohibiting the use of electronic injectors with peripherally inserted central venous catheters (PICCs) not only for CT but also for MRI. Consequently, many institutions mandate hand injection for MR angiography, limiting precision of infusion rates and durations of delivery. OBJECTIVE: To determine whether electronic injection of gadolinium-based contrast media through a range of small-caliber, single-lumen PICCs would be safe without risk of catheter rupture over the range of clinical protocols and determine whether programmed flow rates and volumes were realized when using PICCs for contrast delivery. MATERIALS AND METHODS: Experiments were performed and recorded using the Medrad Spectris Solaris EP MR Injection System. PICC sizes, contrast media and flow rates were based on common institutional protocols. RESULTS: No catheters were damaged during any experiments. Mean difference between programmed and delivered volume was 0.07 ± 0.10 mL for all experiments. Reduced flow rates and prolonged injection durations were observed when the injector's pressure-limiting algorithm was triggered, only in protocols outside the clinical range. CONCLUSION: PICCs commonly used in children can withstand in vitro power injection of gadolinium-based contrast media at protocols significantly above clinical levels.
Central Venous Catheters , Contrast Media/administration & dosage , Equipment Failure Analysis , Equipment Failure , Meglumine/analogs & derivatives , Organometallic Compounds/administration & dosage , Equipment Safety , Injections, Intravenous , Meglumine/administration & dosage
