Abbot R Laptook1, Seetha Shankaran2, Patrick Barnes3, Nancy Rollins4, Barbara T Do5, Nehal A Parikh6, Shannon Hamrick7, Susan R Hintz8, Jon E Tyson9, Edward F Bell10, Namasivayam Ambalavanan11, Ronald N Goldberg12, Athina Pappas2, Carolyn Huitema13, Claudia Pedroza9, Aasma S Chaudhary14, Angelita M Hensman15, Abhik Das13, Myra Wyckoff16, Amir Khan8, Michelle C Walsh17, Kristi L Watterberg18, Roger Faix19, William Truog20, Ronnie Guillet21, Gregory M Sokol22, Brenda B Poindexter23, Rosemary D Higgins24. 1. Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI. Electronic address: alaptook@wihri.org. 2. Department of Pediatrics, Wayne State University, Detroit, MI. 3. Department of Radiology and Pediatrics, Stanford University School of Medicine, Palo Alto, CA. 4. Department of Radiology, University of Texas Southwestern Medical Center, Dallas, TX. 5. Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC. 6. Perinatal Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH. 7. Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta, GA. 8. Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA. 9. Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX. 10. Department of Pediatrics, University of Iowa, Iowa City, IA. 11. Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL. 12. Department of Pediatrics, Duke University, Durham, NC. 13. Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, MD. 14. Department of Pediatrics, University of Pennsylvania, Philadelphia, PA. 15. Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI. 16. Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX. 17. Department of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH. 18. University of New Mexico Health Sciences Center, Albuquerque, NM. 19. Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City, UT. 20. Department of Pediatrics, Children's Mercy Hospital and University of Missouri Kansas City School of Medicine, Kansas City, MO. 21. University of Rochester School of Medicine and Dentistry, Rochester, NY. 22. Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN. 23. Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN; Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH. 24. Eunice Kennedy Shriver National Institute of Child Health and Human Development, Pregnancy and Perinatology Branch, Bethesda, MD; George Mason University, Fairfax, VA.
Abstract
OBJECTIVE: 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. TRIAL REGISTRATION: Clinicaltrials.gov: NCT00614744.
OBJECTIVE: 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. TRIAL REGISTRATION: Clinicaltrials.gov: NCT00614744.
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