Abstract
OBJECTIVE: Among extremely preterm infants, we evaluated whether bevacizumab therapy compared with surgery for retinopathy of prematurity (ROP) is associated with adverse outcomes in early childhood. METHODS: This study was a retrospective analysis of prospectively collected data on preterm (22-26 1 6/7 weeks' gestational age) infants admitted to the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network centers who received bevacizumab or surgery exclusively for ROP. The primary outcome was death or severe neurodevelopmental impairment (NDI) at 18 to 26 months' corrected age (Bayley Scales of Infant and Toddler Development, Third Edition cognitive or motor composite score,70, Gross Motor Functional Classification Scale level $2, bilateral blindness or hearing impairment). RESULTS: The cohort (N = 405; 214 [53%] boys; median [interquartile range] gestational age: 24.6 [23.9-25.3] weeks) included 181 (45%) infants who received bevacizumab and 224 (55%) who underwent ROP surgery. Infants treated with bevacizumab had a lower median (interquartile range) birth weight (640 [541-709] vs 660 [572.5-750] g; P = .02) and longer durations of conventional ventilation (35 [21-58] vs 33 [18-49] days; P = .04) and supplemental oxygen (112 [94-120] vs 105 [84.5-120] days; P = .01). Death or severe NDI (adjusted odds ratio [aOR] 1.42; 95% confidence interval [CI] 0.94 to 2.14) and severe NDI (aOR 1.14; 95% CI 0.76 to 1.70) did not differ between groups. Odds of death (aOR 2.54 [95% CI 1.42 to 4.55]; P = .002), a cognitive score,85 (aOR 1.78 [95% CI 1.09 to 2.91]; P = .02), and a Gross Motor Functional Classification Scale level $2 (aOR 1.73 [95% CI 1.04 to 2.88]; P = .04) were significantly higher with bevacizumab therapy. CONCLUSIONS: In this multicenter cohort of preterm infants, ROP treatment modality was not associated with differences in death or NDI, but the bevacizumab group had higher mortality and poor cognitive outcomes in early childhood. These data reveal the need for a rigorous appraisal of ROP therapy.
| Original language | English (US) |
|---|---|
| Article number | e20183537 |
| Journal | Pediatrics |
| Volume | 144 |
| Issue number | 2 |
| DOIs | |
| State | Published - 2019 |
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
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In: Pediatrics, Vol. 144, No. 2, e20183537, 2019.
Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Neurodevelopmental outcomes of preterm infants with retinopathy of prematurity by treatment
AU - Natarajan, Girija
AU - Shankaran, Seetha
AU - Nolen, Tracy L.
AU - Sridhar, Amaanti
AU - Kennedy, Kathleen A.
AU - Hintz, Susan R.
AU - Phelps, Dale L.
AU - DeMauro, Sara B.
AU - Carlo, Waldemar A.
AU - Gantz, Marie G.
AU - Das, Abhik
AU - Greenberg, Rachel G.
AU - Younge, Noelle E.
AU - Bliss, Joseph M.
AU - Seabrook, Ruth
AU - Sánchez, Pablo J.
AU - Wyckoff, Myra H.
AU - Bell, Edward F.
AU - Vohr, Betty R.
AU - Higgins, Rosemary D.
N1 - Funding Information: The National Institutes of Health, the NICHD, and the National Center for Advancing Translational Sciences provided grant support for the NRN GDB and follow-up studies. The NICHD staff provided input into the study design, conduct, analysis, and drafting of the article; National Center for Advancing Translational Sciences cooperative agreements provided infrastructure support to the NRN. Funding Information: The following investigators, in addition to those listed as authors, participated in this study: NRN Steering Committee Chair: Michael S. Caplan, MD (The University of Chicago Pritzker School of Medicine); Alpert Medical School of Brown University and Women and Infants Hospital of Rhode Island (UG1 HD27904): Abbot R. Laptook, MD, Martin Keszler, MD, Angelita M. Hensman, MS, RNC-NIC, Elisa Vieira, RN, BSN, Emilee Little, RN, BSN, Robert Burke, MD, Melinda Caskey, MD, Katharine Johnson, MD, Barbara Alksninis, PNP, Mary Lenore Keszler, MD, Andrea M. Knoll, Theresa M. Leach, MEd, CAES, Elisabeth C. McGowan, MD, Victoria E. Watson, MS, CAS, and Suzy Ventura; Case Western Reserve University and Rainbow Babies and Children's Hospital (UG1 HD21364): Michele C. Walsh, MD, MS, Avroy A. Fanaroff, MD, Anna Maria Hibbs, MD, MSCE, Nancy S. Newman, BA, RN, Allison H. Payne, MD, MS, Deanne E. Wilson-Costello, MD, Bonnie S. Siner, RN, Monika Bhola, MD, Gulgun Yalcinkaya, MD, and Harriet G. Friedman, MA; Children's Mercy Hospital and University of Missouri-Kansas City School of Medicine (UG1 HD68284): William E. Truog, MD, 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, and Allison Knutson, BSN, RNC-NIC; Cincinnati Children's Hospital Medical Center, University Hospital, and Good Samaritan Hospital (UG1 HD27853, M01 RR8084): Brenda B. Poindexter, MD, MS, Kurt Schibler, MD, Barbara Alexander, RN, Cathy Grisby, BSN, CCRC, Teresa L. Gratton, PA, Jean J. Steichen, MD, Estelle E. Fischer, MHSA, MBA, Lenora Jackson, CRC, Kristin Kirker, CRC, Greg Muthig, BS, Stacey Tepe, BS, and Kimberly Yolton, PhD; Duke University School of Medicine, Duke University Hospital, University of North Carolina at Chapel Hill, and Duke Regional Hospital (UG1 HD40492; UL1 TR1117; UL1 TR1111): Ronald N. Goldberg, MD, C. Michael Cotten, MD, MHS, Ricki F. Goldstein, MD, William F. Malcolm, MD, Patricia L. Ashley, MD, PhD, Kimberley A. Fisher, PhD, FNP-BC, IBCLC, Joanne Finkle, RN, JD, Kathryn E. Gustafson, PhD, Matthew M. Laughon, MD, MPH, Carl L. Bose, MD, Janice Bernhardt, MS, RN, Gennie Bose, RN, and Janice Wereszczak, CPNP-AC/PC; Emory University, Children's Healthcare of Atlanta, Grady Memorial Hospital, and Emory University Hospital Midtown (UG1 HD27851): David P. Carlton, MD, Barbara J. Stoll, MD, Ellen C. Hale, RN, BS, CCRC, Ira Adams-Chapman, MD, Yvonne Loggins, RN, Sheena L. Carter, PhD, Maureen Mulligan LaRossa, RN, Diane I. Bottcher, RN, MSN, and Colleen Mackie, BS, RRT; NICHD: Stephanie Wilson Archer, MA; Indiana University, Indiana University Health University Hospital, Methodist Hospital, Riley Hospital for Children, and Wishard Health Services (UG1 HD27856): Gregory M. Sokol, MD, Brenda B. Poindexter, MD, MS, Lu-Ann Papile, MD, Heidi M. Harmon, MD, MS, Abbey C. Hines, PsyD, Leslie Dawn Wilson, BSN, CCRC, Dianne E. Herron, RN, CCRC, Susan Gunn, NNP, CCRC, and Lucy Smiley, CCRC; McGovern Medical School at The University of Texas Health Science Center at Houston and Children's Memorial Hermann Hospital (UG1 HD87229; U10 HD21373): Jon E. Tyson, MD, MPH, Julie Arldt-McAlister, RN, BSN, Katrina Burson, RN, BSN, Allison G. Dempsey, PhD, Andrea Freeman Duncan, MD, Carmen Garcia, RN, CCRP, Janice John, CPNP, Patrick M. Jones, MD, Layne M. Lillie, RN, BSN, Karen Martin, RN, Sara C. Martin, RN, Georgia E. McDavid, RN, Shawna Rodgers, RN, Saba Siddiki, MD, Daniel Sperry, RN, Patti L. Pierce Tate, RCP, and Sharon L. Wright, MT (American Society for Clinical Pathology); Nationwide Children's Hospital, The Research Institute at Nationwide Children's Hospital, The Ohio State University Wexner Medical Center, The Ohio State University College of Medicine, Center for Perinatal Research at Nationwide Children's Hospital (UG1 HD68278; U10 HD68278): Leif D. Nelin, MD, Sudarshan R. Jadcherla, MD, Christopher Timan, MD, Nathalie L. Maitre, MD, PhD, Patricia Luzader, RN, Julie Gutentag, RN, BSN, Jennifer L. Grothause, BA, RN, BSN, Melanie Stein, RRT, BBS, Rox Ann Sullivan, RN, BSN, Cole D. Hague, BA, MS, Helen Carey, PT, DHSc, Michelle Chao, Stephanie Burkhardt, BS, MPH, Margaret Sullivan, BA, Lina Yossef-Salameh, MD, Jennifer Notestine, RN, Mary Ann Nelin, MD, Erna Clark, BA, Julie C. Shadd, BSN, RD, and Courtney Park, RN, BSN; RTI International (U10 HD36790): Dennis Wallace, PhD, Jamie E. Newman, PhD, MPH, Jeanette O'Donnell Auman, BS, Margaret Crawford, BS, Jenna Gabrio, BS, CCRP, Marie G. Gantz, PhD, Carolyn M. Petrie Huitema, MS, and Kristin M. Zaterka-Baxter, RN, BSN; Stanford University and Lucile Packard Children's Hospital (UG1 HD27880; UL1 TR93): Krisa P. Van Meurs, MD, David K. Stevenson, MD, M. Bethany Ball, BSc, CCRC, Melinda S. Proud, RCP, Barbara Bentley, PsychD MSEd, Maria Elena DeAnda, PhD, Anne M. DeBattista, RN, PNP, PhD, Beth Earhart, PhD, Lynne C. Huffman, MD, Casey E. Krueger, PhD, Ryan Lucash, PhD, and Hali E. Weiss, MD; University of Alabama at Birmingham Health System and Children's Hospital of Alabama (UG1 HD34216): Namasivayam Ambalavanan, MD, Myriam Peralta-Carcelen, MD, MPH, Monica V. Collins, RN, BSN, MaEd, Shirley S. Cosby, RN, BSN, Fred J. Biasini, PhD, Kristen C. Johnston, MSN, CRNP, Cryshelle S. Patterson, PhD, Vivien A. Phillips, RN, BSN, and Sally Whitley, MA, OTR-L, FAOTA; University of California, Los Angeles, Mattel Children's Hospital, Santa Monica Hospital, Los Robles Hospital and Medical Center, and Olive View Medical Center (UG1 HD68270): Uday Devaskar, MD, Meena Garg, MD, Isabell B. Purdy, PhD, CPNP, Teresa Chanlaw, MPH, and Rachel Geller, RN, BSN; University of Iowa and Mercy Medical Center (UG1 HD53109): Tarah T. Colaizy, MD, MPH, Jane E. Brumbaugh, MD, Dan L. Ellsbury, MD, Jonathan M. Klein, MD, Karen J. Johnson, RN, BSN, Jacky R. Walker, RN, Donia B. Campbell, RNC-NIC, and Diane L. Eastman, RN, CPNP, MA; University of New Mexico Health Sciences Center (UG1 HD53089; UL1 TR41): Kristi L. Watterberg, MD, Jean R. Lowe, PhD, Janell F. Fuller, MD, Robin K. Ohls, MD, Conra Backstrom Lacy, RN, Andrea F. Duncan, MD, Tara Dupont, MD, and Elizabeth Kuan, RN, BSN; University of Pennsylvania, Hospital of the University of Pennsylvania, Pennsylvania Hospital, and Children's Hospital of Philadelphia (UG1 HD68244): Barbara Schmidt, MD, MSc, Haresh Kirpalani, MB, MSc, Aasma S. Chaudhary, BS, RRT, Soraya Abbasi, MD, Toni Mancini, RN, BSN, CCRC, Judy C. Bernbaum, MD, Marsha Gerdes, PhD, Hallam Hurt, MD, Noah Cook, MD, and Dara M. Cucinotta, RN; University of Rochester Medical Center, Golisano Children's Hospital, and Women and Children's Hospital of Buffalo (UG1 HD68263; UL1 TR42): Carl T. D'Angio, MD, Ronnie Guillet, MD, PhD, Satyan Lakshminrusimha, MD, Anne Marie Reynolds, MD, MPH, Rosemary L. Jensen, Joan Merzbach, LMSW, Gary J. Myers, MD, Ashley Williams, MSEd, Kelley Yost, PhD, William Zorn, PhD, Karen Wynn, RN, Deanna Maffett, RN, Diane Prinzing, Julianne Hunn, BS, Stephanie Guilford, BS, Farooq Osman, MD, Mary Rowan, RN, Michael G. Sacilowski, BS, Holly I.M. Wadkins, MA, Melissa Bowman, MSN, Linda J. Reubens, RN, CCRC, Cait Fallone, MA, Kyle Binion, BS, Constance Orme, Ann Marie Scorsone, MS, CCRC, and Michelle Andrews-Hartley, MD; University of Texas Southwestern Medical Center, Parkland Health and Hospital System, and Children's Medical Center Dallas (UG1 HD40689): Pablo J. S?nchez, MD, Luc P. Brion, MD, Diana M. Vasil, RNC-NIC, Lijun Chen, PhD, RN, Roy J. Heyne, MD, Sally S. Adams, MS, RN, CPNP, Linda A. Madden, RN, BSN, CPNP, Elizabeth Heyne, PsyD, PA-C, Alicia Guzman; Lizette E. Torres, RN, and Catherine Twell Boatman, MS, CIMI; and Wayne State University, Hutzel Women's Hospital, and Children's Hospital of Michigan (UG1 HD21385): Athina Pappas, MD, Sanjay Chawla, MD, Monika Bajaj, MD, Melissa February, MD, Prashant Agarwal, MD, Kirsten Childs, RN BSN, Eunice Woldt, RN, MSN, Rebecca Bara, RN, BSN, Laura A. Goldston, MA, John Barks, MD, Mary Christensen, RT, Stephanie Wiggins, MS, and Diane White, RT. The National Institutes of Health, the NICHD, and the National Center for Advancing Translational Sciences provided grant support for the NRN GDB and follow-up studies. The NICHD staff provided input into the study design, conduct, analysis, and drafting of the article; National Center for Advancing Translational Sciences cooperative agreements provided infrastructure support to the NRN. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Data collected at participating sites of the NICHD NRN were transmitted to RTI International (the data coordinating center [DCC] for the network), which stored, managed, and analyzed the data included in this study. On behalf of the NRN, Drs Das (DCC principal investigator) and Carla Bann (DCC statistician) had full access to all the data in the study and take responsibility for the integrity of the data and accuracy of the data analysis. We are indebted to our medical and nursing colleagues and the infants and their parents who agreed to take part in this study. Please see Acknowledgments for details of funding grants for the participating Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network centers. Funded by the National Institutes of Health (NIH). Publisher Copyright: Copyright © 2019 by the American Academy of Pediatrics
PY - 2019
Y1 - 2019
N2 - OBJECTIVE: Among extremely preterm infants, we evaluated whether bevacizumab therapy compared with surgery for retinopathy of prematurity (ROP) is associated with adverse outcomes in early childhood. METHODS: This study was a retrospective analysis of prospectively collected data on preterm (22-26 1 6/7 weeks' gestational age) infants admitted to the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network centers who received bevacizumab or surgery exclusively for ROP. The primary outcome was death or severe neurodevelopmental impairment (NDI) at 18 to 26 months' corrected age (Bayley Scales of Infant and Toddler Development, Third Edition cognitive or motor composite score,70, Gross Motor Functional Classification Scale level $2, bilateral blindness or hearing impairment). RESULTS: The cohort (N = 405; 214 [53%] boys; median [interquartile range] gestational age: 24.6 [23.9-25.3] weeks) included 181 (45%) infants who received bevacizumab and 224 (55%) who underwent ROP surgery. Infants treated with bevacizumab had a lower median (interquartile range) birth weight (640 [541-709] vs 660 [572.5-750] g; P = .02) and longer durations of conventional ventilation (35 [21-58] vs 33 [18-49] days; P = .04) and supplemental oxygen (112 [94-120] vs 105 [84.5-120] days; P = .01). Death or severe NDI (adjusted odds ratio [aOR] 1.42; 95% confidence interval [CI] 0.94 to 2.14) and severe NDI (aOR 1.14; 95% CI 0.76 to 1.70) did not differ between groups. Odds of death (aOR 2.54 [95% CI 1.42 to 4.55]; P = .002), a cognitive score,85 (aOR 1.78 [95% CI 1.09 to 2.91]; P = .02), and a Gross Motor Functional Classification Scale level $2 (aOR 1.73 [95% CI 1.04 to 2.88]; P = .04) were significantly higher with bevacizumab therapy. CONCLUSIONS: In this multicenter cohort of preterm infants, ROP treatment modality was not associated with differences in death or NDI, but the bevacizumab group had higher mortality and poor cognitive outcomes in early childhood. These data reveal the need for a rigorous appraisal of ROP therapy.
AB - OBJECTIVE: Among extremely preterm infants, we evaluated whether bevacizumab therapy compared with surgery for retinopathy of prematurity (ROP) is associated with adverse outcomes in early childhood. METHODS: This study was a retrospective analysis of prospectively collected data on preterm (22-26 1 6/7 weeks' gestational age) infants admitted to the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network centers who received bevacizumab or surgery exclusively for ROP. The primary outcome was death or severe neurodevelopmental impairment (NDI) at 18 to 26 months' corrected age (Bayley Scales of Infant and Toddler Development, Third Edition cognitive or motor composite score,70, Gross Motor Functional Classification Scale level $2, bilateral blindness or hearing impairment). RESULTS: The cohort (N = 405; 214 [53%] boys; median [interquartile range] gestational age: 24.6 [23.9-25.3] weeks) included 181 (45%) infants who received bevacizumab and 224 (55%) who underwent ROP surgery. Infants treated with bevacizumab had a lower median (interquartile range) birth weight (640 [541-709] vs 660 [572.5-750] g; P = .02) and longer durations of conventional ventilation (35 [21-58] vs 33 [18-49] days; P = .04) and supplemental oxygen (112 [94-120] vs 105 [84.5-120] days; P = .01). Death or severe NDI (adjusted odds ratio [aOR] 1.42; 95% confidence interval [CI] 0.94 to 2.14) and severe NDI (aOR 1.14; 95% CI 0.76 to 1.70) did not differ between groups. Odds of death (aOR 2.54 [95% CI 1.42 to 4.55]; P = .002), a cognitive score,85 (aOR 1.78 [95% CI 1.09 to 2.91]; P = .02), and a Gross Motor Functional Classification Scale level $2 (aOR 1.73 [95% CI 1.04 to 2.88]; P = .04) were significantly higher with bevacizumab therapy. CONCLUSIONS: In this multicenter cohort of preterm infants, ROP treatment modality was not associated with differences in death or NDI, but the bevacizumab group had higher mortality and poor cognitive outcomes in early childhood. These data reveal the need for a rigorous appraisal of ROP therapy.
UR - http://www.scopus.com/inward/record.url?scp=85071056040&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85071056040&partnerID=8YFLogxK
U2 - 10.1542/peds.2018-3537
DO - 10.1542/peds.2018-3537
M3 - Article
C2 - 31337693
AN - SCOPUS:85071056040
SN - 0031-4005
VL - 144
JO - Pediatrics
JF - Pediatrics
IS - 2
M1 - e20183537
ER -