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Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial

2021; Springer Nature; Volume: 41; Issue: 8 Linguagem: Inglês

10.1038/s41372-021-01018-5

1476-5543

Ira Adams‐Chapman, Kristi L. Watterberg, Tracy L. Nolen, Shawn Hirsch, Carol A. Cole, C. Michael Cotten, William Oh, Brenda B. Poindexter, Kristin M. Zaterka-Baxter, Abhik Das, Conra Backstrom Lacy, Ann Marie Scorsone, Andrea F. Duncan, Sara B. DeMauro, Ricki F. Goldstein, Tarah T. Colaizy, Deanne E. Wilson-Costello, Isabell B. Purdy, Susan R. Hintz, Roy J. Heyne, Gary J. Myers, Janell Fuller, Stephanie L. Merhar, Heidi M. Harmon, Myriam Peralta‐Carcelen, Howard W. Kilbride, Nathalie L. Maitre, Betty R. Vohr, Girija Natarajan, Helen A. Mintz-Hittner, Graham E. Quinn, David K. Wallace, Randall J. Olson, Faruk Örge, Irena Tsui, Michael W. Gaynon, Amy K. Hutchinson, Yu-Guang He, Timothy W. Winter, Michael B. Yang, Kathryn M. Haider, Martin S. Cogen, Denise Hug, Don L. Bremer, John P. Donahue, William R. Lucas, Dale L. Phelps, Rosemary D. Higgins, Stephanie Wilson Archer, Gregory M. Sokol, Susan Gunn, Dianne E. Herron, Abbey C. Hines, Elizabeth Hynes, L.A. Papile, Lucy Smiley, Jon E. Tyson, Kathleen A. Kennedy, Amir Khan, Andi Duncan, Ricardo A. Mosquera, Elizabeth Allain, Julie Arldt-McAlister, Shanti Brown, Allison G. Dempsey, Elizabeth Eason, Farida El-Ali, Carmen Garcia, Kartik Kumar, Janice John, Patrick Jones, M. Layne Lillie, Karen Martin, Sara C. Martin, Georgia E. McDavid, Shannon McKee EdS, Hatice Özsoy, Shawna Rodgers, Daniel K. Sperry, Emily K. Stephens, Vu Ta, Christine Wong, Sharon L. Wright, Pablo J. Sánchez, Leif D. Nelin, Sudarshan R. Jadcherla, Amanda E. Graf, Patricia Luzader, Christine A. Fortney, Gail E. Besner, Nehal A. Parikh, David L. Rogers, Richard P. Golden, Catherine O. Jordan, Dennis Wallace, Marie G. Gantz, Carla Bann, Jeanette O’Donnell Auman, Margaret M. Crawford, Jenna Gabrio, Carolyn M. Petrie Huitema, James W. Pickett, Annie M. VonLehmden, Krisa P. Van Meurs, David K. Stevenson, M. Bethany Ball, Steven B. Chinn, Melinda S. Proud, Barbara Bentley, Maria Elena DeAnda, Anne M. DeBattista, Beth Earhart, Lynne C. Huffman, Casey E. Krueger, Ryan E. Lucash, Hali E. Weiss, Waldemar A. Carlo, Namasivayam Ambalavanan, Monica V. Collins, Shirley S. Cosby, Rebecca J. Quinn, Brenda Denson, Ann Marie Arciniegas-Bernal, Fred J. Biasini, Kristen C. Johnston, Cryshelle S. Patterson, Vivien A. Phillips, Sally Whitley, Uday Devaskar, Meena Garg, Teresa Chanlaw, Rachel Geller, Edward F. Bell, Jane E. Brumbaugh, Karen Johnson, Jacky R. Walker, Claire A. Goeke, Kristine M. Johnson, Angela Merriss, Joanna L. Nohr, Susannah Q. Longmuir, Arlene V. Drack, Diane L. Eastman, Scott A. Larson, Kevin R. Gertsch, Vikki P. Bell, Robin K. Ohls, Sandra Sundquist Beauman, Tara L. DuPont, Mary Ruffaner Hanson, Carol H. Hartenberger, Elizabeth Kuan, Susan J. Kunkel, Jean Lowe, Nancy A. Morgan, Mikko Hallman, Barbara Schmidt, Haresh Kirpalani, Soraya Abbasi, Aasma S. Chaudhary, Toni Mancini, William Anninger, Judy Bernbaum, Gil Binenbaum, Noah Cook, Stefanie L. Davidson, Marsha Gerdes, Hallam Hurt, Monte D. Mills, M. Ricciardelli, Kenneth Rockwell, Jonathan Snyder, S Yau, Carl T. D’Angio, Satyan Lakshminrusimha, Anne Marie Reynolds, Stephen A. Bean, Melissa F. Carmen, Patricia R. Chess, Rosemary L. Jensen, Rajeev S. Ramchandran, Ann Turner, Ashley Williams, Michael G. Sacilowski, Holly I.M. Wadkins, Julianne Hunn, Aimee Horan, Melissa Bowman, Michele Hartley-McAndrew, William Zorn, Osman Farooq, Kelley Yost, Joan Merzbach, Cait Fallone, Kyle Binion, Constance Orme, Premini Sabaratnam, Myra H. Wyckoff, Luc P. Brion, Diana M. Vasil, Samuel B. Adams, Charles Cha, Juana Cisneros, Maria Magdalena Leon, Frances Eubanks, Lynda Godowic, Laura Grau, Alicia Guzman, Elizabeth T. Heyne, Lizette E. Lee, Helen C. Lira, Azadeh Mozaffari, Lara Pavageau, Catherine Twell Boatman, Reshma Wright, Seetha Shankaran, Beena G. Sood, Rebecca Bara, Prashant Agarwal, Monika Bajaj, Sanjay Chawla, Kirsten Childs, Melissa February, Laura A. Goldston, Mary E. Johnson, Mirjana Lulic‐Botica, Bogdan Panaitescu, Eunice Woldt, Christine A. Gleason, Marilee C Allen, Robert Boyle, Traci E. Clemons, Mary E. D’Alton, Abhik Das, Donald F. Everett, Ralph E. Kauffman, Menachem Miodovnik, T. Michael O’Shea, Lois Smith, Steven J. Weiner, Marian Willinger,

Neonatal Respiratory Health Research

This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial. Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial. Moderate/severe NDI was defined as BSID-III Cognitive or Motor composite score <85, moderate or severe cerebral palsy, blindness, or hearing loss that prevents communication despite amplification were assessed. Primary outcome was determined for 605/638 (95%). The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40). Treatment group did not affect the risk of death or survival with moderate/severe NDI. Despite early termination, this study represents the largest RCT of extremely preterm infants treated with myo-inositol with neurodevelopmental outcome data.