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

• DOI: 10.1038/s41372-021-01018-5
• Publication Date: 2021-03-23T08:02:50Z
• Authors: Ira Adams-Chapman; Kristi L. Watterberg; Tracy L. Nolen; Shawn Hirsch; Carol A. Cole; C. Michael Cotten; William Oh; Brenda B. Poindexter; Kristin M. Zaterk...; Abhik Das; Conra Backstrom Lacy; Ann Marie Scorsone; Andrea F. Duncan; Sara B. DeMauro; Ricki F. Goldstein; Tarah T. Colaizy; Deanne E. Wilson-...; Isabell B. Purdy; Susan R. Hintz; Roy J. Heyne; Gary J. Myers; Janell Fuller; Stephanie Merhar; Heidi M. Harmon; Myriam Peralta-Ca...; Howard W. Kilbride; Nathalie L. Maitre; Betty R. Vohr; Girija Natarajan; Helen Mintz-Hittner; Graham E. Quinn; David K. Wallace; Richard J. Olson; Faruk H. Orge; Irena Tsui; Michael 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 ...; Gregory M. Sokol; Susan Gunn; Dianne E. Herron; Abbey C. Hines; Elizabeth Hynes; Lu-Ann Papile; Lucy Smiley; Jon E. Tyson; Kathleen A. Kennedy; Amir M. Khan; Andi Duncan; Ricardo Mosquera; Elizabeth Allain; Julie Arldt-McAli...; Shanti Brown; Allison G. Dempsey; Elizabeth Eason; Farida El-Ali; Carmen Garcia; Kartik Kumar; Janice John; Patrick M. Jones; M. Layne Lillie; Karen Martin; Sara C. Martin; Georgia E. McDavid; Shannon McKee EdS; Hatice Ozsoy; Shawna Rodgers; Daniel Sperry; Emily K. Stephens; Vu Ta; Christine Wong; Sharon L. Wright; Pablo J. Sánchez; Leif D. Nelin; Sudarshan R. Jadc...; Amanda E. Graf; Patricia Luzader; Christine A. Fortney; Gail E. Besner; Nehal A. Parikh; David L. Rogers; Richard P. Golden; Catherine Olson J...; Dennis Wallace; Marie G. Gantz; Carla M. Bann; Jeanette O’ Donne...; Margaret M. Crawford; Jenna Gabrio; Carolyn M. Petrie...; James W. Pickett; Annie M. VonLehmden; Krisa P. Van Meurs; David K. Stevenson; M. Bethany Ball; Steven Chinn; Melinda S. Proud; Barbara Bentley; Maria Elena DeAnda; Anne M. DeBattista; Beth Earhart; Lynne C. Huffman; Casey E. Krueger; Ryan Lucash; Hali E. Weiss; Waldemar A. Carlo; Namasivayam Ambal...; Monica V. Collins; Shirley S. Cosby; Rebecca J. Quinn; Brenda Reed Denson; Ann Marie Arcinie...; Fred J. Biasini; Kristen C. Johnston; Cryshelle S. Patt...; Vivien A. Phillips; Sally Whitley; Uday Devaskar; Meena Garg; Teresa Chanlaw; Rachel Geller; Edward F. Bell; Jane E. Brumbaugh; Karen J. 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 ...; Tara Dupont; Mary Ruffaner Hanson; Carol H. Hartenbe...; Elizabeth Kuan; Susan J. Kunkel; Jean Lowe; Nancy A. Morgan; Mikko K. Hallman; Barbara Schmidt; Haresh Kirpalani; Soraya Abbasi; Aasma S. Chaudhary; Toni Mancini; William V. Anninger; Judy C. Bernbaum; Gil Binenbaum; Noah Cook; Stefanie L. Davidson; Marsha Gerdes; Hallam Hurt; Monte D. Mills; Mina Ricciardelli; Kenneth Rockwell; Jonathan Snyder; Sze Man Yau; Carl D’Angio; Satyan Lakshminru...; Anne Marie Reynolds; Stephen A. Bean; Melissa F. Carmen; Patricia R. Chess; Rosemary Jensen; Rajeev S. Ramchan...; Ann Marie Turner; Ashley Williams; Michael G. Sacilo...; Holly Wadkins; Julianne Hunn; Aimee Horan; Melissa Bowman; Michele Hartley-M...; 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; Sally S. Adams; Christine Cha; Juana Cisneros; Maria M. De Leon; Frances Eubanks; Lynda Godowic; Laura Grau; Alicia Guzman; Elizabeth Heyne; Lizette E. Lee; Helen C. Lira; Azadeh Mozaffari; Lara Pavageau; Catherine Twell B...; 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 J. Boyle; Traci Clemons; Mary E. D’Alton; Abhik Das; Donald Everett; Ralph E. Kauffman; Menachem Miodovnik; T. Michael O’Shea; Lois Smith; Steven J. Weiner; Marian Willinger
• Keywords: 03 medical and health sciences; Child Development; 0302 clinical medicine; Cerebral Palsy; Infant, Extremely Premature; Infant, Newborn; Humans; Gestational Age; Inositol; 3. Good health

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.