- Browse by Author
Browsing by Author "Rollins, Nancy"
Now showing 1 - 2 of 2
Results Per Page
Sort Options
Item Integrating neuroimaging biomarkers into the multicentre, high-dose erythropoietin for asphyxia and encephalopathy (HEAL) trial: rationale, protocol and harmonisation(BMJ, 2021-04-22) Wisnowski, Jessica L.; Bluml, Stefan; Panigrahy, Ashok; Mathur, Amit M.; Berman, Jeffrey; Chen, Ping-Sun Keven; Dix, James; Flynn, Trevor; Fricke, Stanley; Friedman, Seth D.; Head, Hayden W.; Ho, Chang Y.; Kline-Fath, Beth; Oveson, Michael; Patterson, Richard; Pruthi, Sumit; Rollins, Nancy; Ramos, Yanerys M.; Rampton, John; Rusin, Jerome; Shaw, Dennis W.; Smith, Mark; Tkach, Jean; Vasanawala, Shreyas; Vossough, Arastoo; Whitehead, Matthew T.; Xu, Duan; Yeom, Kristen; Comstock, Bryan; Heagerty, Patrick J.; Juul, Sandra E.; Wu, Yvonne W.; McKinstry, Robert C.; Radiology and Imaging Sciences, School of MedicineIntroduction: 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.Item Limitations of Conventional Magnetic Resonance Imaging as a Predictor of Death or Disability Following Neonatal Hypoxic-Ischemic Encephalopathy in the Late Hypothermia Trial(Elsevier, 2021) Laptook, Abbot R.; Shankaran, Seetha; Barnes, Patrick; Rollins, Nancy; Do, Barbara T.; Parikh, Nehal A.; Hamrick, Shannon; Hintz, Susan R.; Tyson, Jon E.; Bell, Edward F.; Ambalavanan, Namasivayam; Goldberg, Ronald N.; Pappas, Athina; Huitema, Carolyn; Pedroza, Claudia; Chaudhary, Aasma S.; Hensman, Angelita M.; Das, Abhik; Wyckoff, Myra; Khan, Amir; Walsh, Michelle C.; Watterberg, Kristi L.; Faix, Roger; Truog, William; Guillet, Ronnie; Sokol, Gregory M.; Poindexter, Brenda B.; Higgins, Rosemary D.; Eunice Kennedy Shriver National Institute of Child Health; Human Development Neonatal Research Network; Pediatrics, School of MedicineObjective: To investigate if magnetic resonance imaging (MRI) is an accurate predictor for death or moderate-severe disability at 18-22 months of age among infants with neonatal encephalopathy in a trial of cooling initiated at 6-24 hours. Study design: Subgroup analysis of infants ≥36 weeks of gestation with moderate-severe neonatal encephalopathy randomized at 6-24 postnatal hours to hypothermia or usual care in a multicenter trial of late hypothermia. MRI scans were performed per each center's practice and interpreted by 2 central readers using the Eunice Kennedy Shriver National Institute of Child Health and Human Development injury score (6 levels, normal to hemispheric devastation). Neurodevelopmental outcomes were assessed at 18-22 months of age. Results: Of 168 enrollees, 128 had an interpretable MRI and were seen in follow-up (n = 119) or died (n = 9). MRI findings were predominantly acute injury and did not differ by cooling treatment. At 18-22 months, death or severe disability occurred in 20.3%. No infant had moderate disability. Agreement between central readers was moderate (weighted kappa 0.56, 95% CI 0.45-0.67). The adjusted odds of death or severe disability increased 3.7-fold (95% CI 1.8-7.9) for each increment of injury score. The area under the curve for severe MRI patterns to predict death or severe disability was 0.77 and the positive and negative predictive values were 36% and 100%, respectively. Conclusions: MRI injury scores were associated with neurodevelopmental outcome at 18-22 months among infants in the Late Hypothermia Trial. However, the results suggest caution when using qualitative interpretations of MRI images to provide prognostic information to families following perinatal hypoxia-ischemia.