Darbepoetin, Red Cell Mass, and Neuroprotection in Preterm Infants

作者：Robin K. Ohls, Abhik Das, Sylvia Tan, Jean Lowe, Kurt Schibler, Sandra Sundquist Beauman, Edward F. Bell, Abbot R. Laptook, Mariana Baserga, Ravi M. Patel, David P. Carlton, John Flibotte, Cathy Grisby, Rosemary D. Higgins, Seetha Shankaran, Kristi L. Watterberg, Anna Maria Hibbs, Waldemar A. Carlo, Tarah T. Colaizy, Krisa P. Van Meurs, Stephen D. Kicklighter, Ryan Moore, Christina Sollinger, Lina F. Chalak, Sarvin Ghavam, Brenda B. Poindexter, Jon E. Tyson, C. Michael Cotten, Michelle Baack, Omid Fathi, Sara B. DeMauro, Matthew M. Laughon, Ann Marie Reynolds, Andrea Duncan, Sarah Winter, Deanne E. Wilson-Costello, Myriam Peralta-Carcelén, Betty R. Vohr, Heidi M. Harmon, Susan R. Hintz, Brenna Cavanaugh, Roy J. Heyne, Stephanie L. Merhar, Ricardo A. Mosquera, Elizabeth Sewell, William Malcolm, Laurie A. Richards, Kristen Benninger, Andrea Trembath, Andrew A. Bremmer, Stephanie Wilson Archer, Traci Heath Mondoro, Richard A. Polin, Martin Keszler, Angelita M. Hensman, Elisa Vieira, Lucille St. Pierre, Barbara Alksninis, Andrea M. Knoll, Mary Lenore Keszler, Teresa M. Leach, Elisabeth C. McGowan, Victoria E. Watson, Nancy S. Newman, Bonnie S. Siner, Elizabeth Roth, Tanya E. Cahill, Kristin Kirker, Sandra Wuertz, Juanita Dudley, Julia Thompson, Lisa Henkes, Sara Stacey, Devan Hayes, Traci Beiersdorfer, Ronald N. Goldberg, Patricia L. Ashley, Deesha Mago-Shah, Mollie Warren, Joanne Propst, Kimberley A. Fisher, Kathryn E. Gustafson, Cindy Clark, Gennie Bose, Janice Wereszczak, Jennifer Talbert, Alexandra Bentley, Laura Edwards, Donna L. White, Ira Adams‐Chapman, Yvonne Loggins, Diane I. Bottcher, Sheena L. Carter, Salathiel Kendrick-Allwood, Maureen Mulligan LaRossa, Judith Laursen, Colleen Mackie, Amy Sanders, Gloria V. Smikle, Lynn Wineski, Amir M. Khan, Barbara J. Stoll, Nora I. Alaniz, Fatima Boricha, Allison G. Dempsey, Donna J. Hall, Janice John, Ann Kubanda, Karen Martin, Georgia E. McDavid, Kimberly Rennie, Daniel K. Sperry, Emily K. Stephens, Tina Reddy, Michelle E. White, Sharon L. Wright, Krysten Webber, Dinorah Zanger, Leif D. Nelin, Jonathan L. Slaughter, Sudarshan R. Jadcherla, Christopher Tinman, Patricia Luzader, Demi R. Beckford, Julie Gutentag, Melanie Stein, Rox Ann Sullivan, Mary Ann Nelin, Kristi Small, Jacqueline McCool, Lindsay Pietruszewski, Jessica Purnell, Kyrstin Warnimont, Laura Marzec, Bethany Miller, Hallie Baugher, Julia L. Newton, Katelyn Levengood, Nancy Batterson, Brittany DeSantis, Jessica Schiering, Kelly Schmidt, Eduardo Finol Mark, Jordan Knox, Abbie M. Tice, Chelsea Cobe, Marissa Trotta, Emily Smith, Jeanette O’Donnell Auman, James Pickett, Anna Mazur, Jamie E. Newman, Lindsay Parlberg, Kristin M. Zaterka-Baxter, Valerie Y. Chock, David K. Stevenson, Dona Bahmani, Elizabeth N. Reichert, Lilia Rutkowska, M. Bethany Ball, Meera N. Sankar, Anne M. DeBattista, Barbara P. Recine, Casey E. Krueger, Hali E. Weiss, Heather Taylor, Janice Lowe, Jessica Patel, Lynne C. Huffman, Maria Elena DeAnda, Namasivayam Ambalavanan, Fred J. Biasini, Shirley S. Cosby, Kristy A. Domnanovich, Chantel J. Jno-Finn, Morissa Ladinsky, Tara E. McNair, Kimberlly Stringer, Sally Whitley, Sheree York Chapman, Cindie Buie, Jane E. Brumbaugh, Karen Johnson, Mendi L. Schmelzel, Jacky R. Walker, Claire A. Goeke, Diane L. Eastman, Megan M. Henning, Chelsey Elekiwich, Megan Broadbent, Sarah Van Muyden, Dan L. Ellsbury, Tracy L. Tud, Janell Fuller, C J Lacey, Carol Hartenberger, Mary Hanson, Elizabeth Kuan, Eric C. Eichenwald, Karen M. Pupolo, Aasma S. Chaudhary, Toni Mancini, Jonathan Snyder, Kristina Ziolkowski, Megan Dhawan, Christina Catts, Ronnie Guillet, Rosemary L. Jensen, Joanne Merzbach, Osman Farooq, Ann Marie Scorsone, Constance Orme, Rachel Jones, Elizabeth Boylin, Jennifer Kachelmeyer, Kimberly G. McKee, Kelly R. Coleman, Deanna Maffett, Alison L. Kent, Carl T. D’Angio, Cassandra A. Horihan, Satyan Lakshminrusimha, William Zorn, Michelle Hartley-McAndrew, Lei Li, Myra H. Wyckoff, Luc P. Brion, Diana M. Vasil, Frances Eubanks, E. Rebecca McDougald, Pollieanna Sepulveda, Elizabeth T. Heyne, Lizette E. Lee, Anna E. Puentez, Azucena Vera, Jillian Waterbury, Cathy Twell Boatman, Kristine Tolentino-Plata, Bradley A. Yoder, Carrie A. Rau, Shawna Baker, Sean D. Cunningham, Becky Hall, Erika R. Jensen, Manndi C. Loertscher, Trisha Marchant, Kandace M. McGrath, Hena G. Mickelsen, Galina Morshedzadeh, Kelly Stout, Ashley L. Stuart, Kathryn D. Woodbury, Dawn Bentley, Laura Cole Bledsoe, Kathleen Coleman, Brixen A. Reich, Micall P. Sagers, Stephen D. Minton, Erick Gerday, Susan Christensen, Jennifer O. Elmont, Mark J. Sheffield, Melody Parry, Jamie Jordan, Katherine Tice, Earl Maxson, Barbara L. Francom, Kimberlee Weaver-Lewis, Tara L. DuPont · 发表于：Archives of Pediatrics and Adolescent Medicine · 年份：2025 · DOI：10.1001/jamapediatrics.2025.0807 · 被引用次数：14 · 研究领域：Erythropoietin and Anemia Treatment、Neonatal Respiratory Health Research、Neonatal and fetal brain pathology

Importance: Previous studies suggest that administration of erythropoiesis-stimulating agents darbepoetin or erythropoietin to preterm infants results in fewer transfusions, fewer donor exposures, and improved neurodevelopmental outcome. Objective: To determine if, compared with placebo, preterm infants randomized to weekly darbepoetin would have greater red cell mass during hospitalization and better neurocognitive outcome at 22 to 26 months' corrected age. Design, Setting, and Participants: This randomized clinical trial was conducted between September 2017 and November 2019 for infants 23 0/7 to 28 6/7 weeks' gestation in 19 US Neonatal Research Network centers comprising 33 neonatal intensive care units. Follow-up occurred through January 2023. Infants were randomized by 36 hours after birth to weekly placebo or darbepoetin (10 μg/kg) through 35 weeks' postmenstrual age. Iron administration and transfusions were administered by protocol. Study data were analyzed from June to October 2023. Main Outcomes and Measures: The primary outcome was the mean cognitive composite score on the Bayley Scales of Infant Development, third edition (Bayley-III) at 22 to 26 months' corrected age. The lowest possible score (54) was assigned to infants who died. Results: A total of 650 infants (322 darbepoetin; 328 placebo; mean [SD] gestational age, 26.2 [1.7] weeks; 328 female [50.5%]) were enrolled. Five hundred eighty-three infants (291 darbepoetin; 292 placebo) had the primary outcome de...