Limitations of Conventional Magnetic Resonance Imaging as a Predictor of Death or Disability Following Neonatal Hypoxic–Ischemic Encephalopathy in the Late Hypothermia Trial - 22/02/21
Doi : 10.1016/j.jpeds.2020.11.015
Abbot R. Laptook, MD 1, ⁎, † 
, Seetha Shankaran, MD 2, Patrick Barnes, MD 3, Nancy Rollins, MD 4, Barbara T. Do, MSPH 6, Nehal A. Parikh, DO, MS 7, Shannon Hamrick, MD 8, Susan R. Hintz, MD, MS 9, Jon E. Tyson, MD, MPH 10, Edward F. Bell, MD 11, Namasivayam Ambalavanan, MD 12, Ronald N. Goldberg, MD 13, Athina Pappas, MD 2, Carolyn Huitema, MS 14, Claudia Pedroza, PhD 10, Aasma S. Chaudhary, BS, RRT 15, Angelita M. Hensman, PhD, RNC-NIC 1, Abhik Das, PhD 14, Myra Wyckoff, MD 5, Amir Khan, MD 9, Michelle C. Walsh, MD, MS 16, Kristi L. Watterberg, MD 17, Roger Faix, MD 18, William Truog, MD 19, Ronnie Guillet, MD, PhD 20, Gregory M. Sokol, MD 21, Brenda B. Poindexter, MD, MS 21, 22, Rosemary D. Higgins, MD 23, 24
for the
, Seetha Shankaran, MD 2, Patrick Barnes, MD 3, Nancy Rollins, MD 4, Barbara T. Do, MSPH 6, Nehal A. Parikh, DO, MS 7, Shannon Hamrick, MD 8, Susan R. Hintz, MD, MS 9, Jon E. Tyson, MD, MPH 10, Edward F. Bell, MD 11, Namasivayam Ambalavanan, MD 12, Ronald N. Goldberg, MD 13, Athina Pappas, MD 2, Carolyn Huitema, MS 14, Claudia Pedroza, PhD 10, Aasma S. Chaudhary, BS, RRT 15, Angelita M. Hensman, PhD, RNC-NIC 1, Abhik Das, PhD 14, Myra Wyckoff, MD 5, Amir Khan, MD 9, Michelle C. Walsh, MD, MS 16, Kristi L. Watterberg, MD 17, Roger Faix, MD 18, William Truog, MD 19, Ronnie Guillet, MD, PhD 20, Gregory M. Sokol, MD 21, Brenda B. Poindexter, MD, MS 21, 22, Rosemary D. Higgins, MD 23, 24for the
Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network∗
Michael S. Caplan, MD, Richard A. Polin, MD, Martin Keszler, MD, William Oh, MD, Betty R. Vohr, MD, Elizabeth C. McGowan, MD, Barbara Alksninis, RNC, PNP, Kristin Basso, MaT, RN, Joseph Bliss, MD, PhD, Carmena Bishop, Robert T. Burke, MD, MPH, William Cashore, MD, Melinda Caskey, MD, Dan Gingras, RRT, Nicholas Guerina, MD, PhD, Katharine Johnson, MD, Mary Lenore Keszler, MD, Andrea M. Knoll, Theresa M. Leach, Med, CAES, Martha R. Leonard, BA, BS, Emilee Little, RN, BSN, Bonnie E. Stephens, MD, Elisa Vieira, RN, BSN, Victoria E. Watson, MS, CAS, Anna Maria Hibbs, MD, Deanne E. Wilson-Costello, MD, Nancy S. Newman, RN, Beau Batton, MD, Monika Bhola, MD, Juliann M. Di Fiore, BSEE, Harriet G. Friedman, MA, Bonnie S. Siner, RN, Eileen K. Stork, MD, Gulgun Yalcinkaya, MD, Arlene Zadell, RN, Eugenia K. Pallotto, MD, MSCE, Howard W. Kilbride, MD, Cheri Gauldin, RN, BS, CCRC, Anne Holmes, RN, MSN, MBA-HCM, CCRC, Kathy Johnson, RN, CCRC, Allison Knutson, BSN, RNC-NIC, Kurt Schibler, MD, Kimberly Yolton, PhD, Cathy Grisby, BSN CCRC, Teresa L. Gratton, PA, Stephanie Merhar, MD MS, Sandra Wuertz, RN, BSN, CLC, C. Michael Cotten, MD, MHS;, Kimberley A. Fisher, PhD, FNP-BC, IBCLC, Sandra Grimes, RN, BSN, Joanne Finkle, RN, JD, Ricki F. Goldstein, MD, Kathryn E. Gustafson, PhD, William F. Malcolm, MD, Patricia L. Ashley, MD, PhD, Kathy J. Auten, MSHS, Melody B. Lohmeyer, RN, MSN, Matthew M. Laughon, MD MPH, Carl L. Bose, MD, Janice Bernhardt, MS, RN, Cindy Clark, RN, Diane D. Warner, MD, MPH, Janice Wereszcsak, CPNP, Sofia Aliaga, MD, MPH, David P. Carlton, MD, Barbara J. Stoll, MD, Ellen C. Hale, RN, BS, CCRC, Yvonne Loggins, RN, Diane I. Bottcher, MSN, RN, Colleen Mackie, BS, RT, Maureen Mulligan LaRossa, RN, Ira Adams-Chapman, MD, Lynn C. Wineski, RN, MS, Sheena L. Carter, PhD, Rosemary D. Higgins, MD, Stephanie Wilson Archer, MA, Heidi M. Harmon, MD MS, Lu-Ann Papile, MD, Anna M. Dusick, MD (deceased), Susan Gunn, NNP-BC CCRC, Dianne E. Herron, RN CCRC, Abbey C. Hines, PsyD, Darlene Kardatzke, MD (deceased), Carolyn Lytle, MD MPH, Heike M. Minnich, PsyD HSPP, Leslie Richard, RN, Lucy C. Smiley, CCRC, Leslie Dawn Wilson, BSN, CCRC, Kathleen A. Kennedy, MD, MPH, Elizabeth Allain, MS, Carrie M. Mason, MA, LPA, Julie Arldt-McAlister, MSN, APRN, Katrina Burson, RN, BSN, Allison G. Dempsey, PhD, Andrea F. Duncan, MD, MSClinRes, Patricia W. Evans, MD, Carmen Garcia, RN, BSN, Charles E. Green, PhD, Margarita Jimenez, MD, MPH, Janice John, CPNP, Patrick M. Jones, MD, MA, M. Layne Lillie, RN, BSN, Karen Martin, RN, Sara C. Martin, RN, BSN, Georgia E. McDavid, RN, Shannon McKee, EdS, Patti L. Pierce Tate, RCP, Shawna Rodgers, RN, BSN, Saba Khan Siddiki, MD, Daniel K. Sperry, RN, Sharon L. Wright, MT (ASCP), Pablo J. Sánchez, MD, Leif D. Nelin, MD, Sudarshan R. Jadcherla, MD, Patricia Luzader, RN, Christine A. Fortney, PhD RN, Jennifer L. Grothause, BA, RN, BSN, Dennis Wallace, PhD, Marie G. Gantz, PhD, Kristin M. Zaterka-Baxter, RN, BSN CCRP, Margaret M. Crawford, BS, CCRP, Scott A. McDonald, BS, Jamie E. Newman, PhD, MPH, Jeanette O'Donnell Auman, BS, Carolyn M. Petrie Huitema, MS, CCRP, James W. Pickett, BS, Patricia Yost, BS, Krisa P. Van Meurs, MD, David K. Stevenson, MD, M. Bethany Ball, BSc CCRC, Barbara Bentley, PsychD, MS, Ed, Valerie Y. Chock, MD MS Epi;, Elizabeth F. Bruno, PhD, Alexis S. Davis, MD, MS, EPI, Maria Elena DeAnda, PhD, Anne M. DeBattista, RN, PNP, PhD, Beth Earhart, PhD, Lynne C. Huffman, MD, Jean G. Kohn, MD, MPH, Casey E. Krueger, PhD, Melinda S. Proud, RCP, William D. Rhine, MD, Nicholas H. St. John, PhD, Heather Taylor, PhD, Hali E. Weiss, MD, Waldemar A. Carlo, MD, Myriam Peralta-Carcelen, MD MPH, Monica V. Collins, RN, BSN MaEd, Shirley S. Cosby, RN BSN, Vivien A. Phillips, RN BSN, Richard V. Rector, PhD, Sally Whitley, MA OTR-L FAOTA, Tarah T. Colaizy, MD, MPH, Jane E. Brumbaugh, MD, Karen J. Johnson, RN, BSN, Diane L. Eastman, RN, CPNP, MA, Michael J. Acarregui, MD, MBA, Jacky R. Walker, RN, Claire A. Goeke, RN, Jonathan M. Klein, MD, Nancy J. Krutzfield, RN, MA, Jeffrey L. Segar, MD, John M. Dagle, MD, PhD, Julie B. Lindower, MD, MPH, Steven J. McElroy, MD, Glenda K. Rabe, MD, MME, Robert D. Roghair, MD, Lauritz R. Meyer, MD, Dan L. Ellsbury, MD, Donia B. Campbell, RNC-NIC, Cary R. Murphy, MD, Vipinchandra Bhavsar, MB, BS, Robin K. Ohls, MD, Conra Backstrom Lacy, RN, Sandra Sundquist Beauman, MSN, RNC, Sandra Brown, BSN, Erika Fernandez, MD, Andrea Freeman Duncan, MD, Janell Fuller, MD, Elizabeth Kuan, RN, BSN, Jean R. Lowe, PhD, Barbara Schmidt, MD MSc, Haresh Kirpalani, MB, MSc, Sara B. DeMauro, MD, MSCE, Kevin C. Dysart, MD, Soraya Abbasi, MD, Toni Mancini, RN, BSN, CCRC, Dara M. Cucinotta, RN, Judy C. Bernbaum, MD, Marsha Gerdes, PhD, Hallam Hurt, MD, Carl D'Angio, MD, Satyan Lakshminrusimha, MD, Nirupama Laroia, MD, Gary J. Myers, MD, Kelley Yost, PhD, Stephanie Guilford, BS, Rosemary L. Jensen, Karen Wynn, NNP, RN, Osman Farooq, MD, Anne Marie Reynolds, MD, MPH, Holly I.M. Wadkins, MA, Ashley Williams, MS, Ed, Joan Merzbach, LMSW, Patrick Conway, MS, Melissa Bowman, MSN, Michele Hartley-McAndrew, MD, William Zorn, PhD, Cait Fallone, MA, Kyle Binion, BS, Constance Orme, Ann Marie Scorsone, MS, CCRC, Ashley Williams, Luc P. Brion, MD, Lina F. Chalak, MD MSCS, Roy J. Heyne, MD, Lijun Chen, PhD RN, Diana M. Vasil, MSN BSN RNC-NIC, Sally S. Adams, MS RN CPNP, Catherine Twell Boatman, MS, CIMI, Alicia Guzman, Elizabeth T. Heyne, MS MA PA-C PsyD, Lizette E. Lee, RN, Melissa H. Leps, RN, Linda A. Madden, BSN RN CPNP, Nancy A. Miller, RN, Emma Ramon, RNC-NIC, RN, BSN, Bradley A. Yoder, MD, Karen A. Osborne, RN, BSN, CCRC, Cynthia Spencer, RNC, R. Edison Steele, RN, Mike Steffen, PhD, Karena Strong, RN, BSN, Kimberlee Weaver-Lewis, RN, BSN, Shawna Baker, RN, Sarah Winter, MD, Karie Bird, RN BSN, Jill Burnett, RNC, BSN, Beena G. Sood, MD, MS, Rebecca Bara, RN, BSN, Kirsten Childs, RN, BSN, Lilia C. De Jesus, MD, Bogdan Panaitescu, MD, Sanjay M.D. Chawla, Jeannette E. Prentice, MD, Laura A. Goldston, MA, Eunice Hinz Woldt, RN, MSN, Girija Natarajan, MD, Monika Bajaj, MD, John Barks, MD, Mary Christensen, RT, Stephanie A. Wiggins, MS
1 Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI
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 Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX
6 Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC
7 Perinatal Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH
8 Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta, GA
9 Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA
10 Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX
11 Department of Pediatrics, University of Iowa, Iowa City, IA
12 Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL
13 Department of Pediatrics, Duke University, Durham, NC
14 Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, MD
15 Department of Pediatrics, University of Pennsylvania, Philadelphia, PA
16 Department of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH
17 University of New Mexico Health Sciences Center, Albuquerque, NM
18 Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City, UT
19 Department of Pediatrics, Children's Mercy Hospital and University of Missouri Kansas City School of Medicine, Kansas City, MO
20 University of Rochester School of Medicine and Dentistry, Rochester, NY
21 Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN
22 Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH
23 Eunice Kennedy Shriver National Institute of Child Health and Human Development, Pregnancy and Perinatology Branch, Bethesda, MD
24 George Mason University, Fairfax, VA
∗Reprint requests: Abbot R. Laptook, MD, Women & Infants Hospital of Rhode Island, 101 Dudley St, Providence, RI 02905.Women & Infants Hospital of Rhode Island101 Dudley StProvidenceRI02905
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.
Le texte complet de cet article est disponible en PDF.Keywords : imaging, hypoxic-ischemic encephalopathy, brain cooling
Abbreviations : ALIC, BGT, HIE, MRI, NAIS, NICHD, NRN, PLIC, RCT
Plan
| The National Institutes of Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Center for Research Resources, and the National Center for Advancing Translational Sciences provided grant support for the Neonatal Research Network's Late Hypothermia Trial (recruitment April 17, 2008, to July 13, 2014, and follow-up from October 17, 2009, to September 12, 2016) through cooperative agreements. Participating Neonatal Research Network sites collected data and transmitted it to RTI International, the data coordinating center (DCC) for the network, which stored, managed, and analyzed the data for this study. While NICHD staff did have input into the study design, conduct, analysis, and manuscript drafting, the content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. On behalf of the NRN, A.D. (DCC Principal Investigator), Breda Munoz, PhD, and B.D. (DCC Statistician) had full access to all of the data in the study, and with the NRN Center Principal Investigators, take responsibility for the integrity of the data and accuracy of the data analysis. The authors declare no conflicts of interest. |
© 2020
Elsevier Inc. Tous droits réservés.
Vol 230
P. 106 - mars 2021 Retour au numéro
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